Duloxetine
Capsule, Delayed Release · Oral
Uses
Duloxetine Delayed-Release Capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Duloxetine Delayed-Release Capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 )
Dosage and administration
Do not initiate treatment with Duloxetine Delayed-Release Capsules. Use another duloxetine delayed-release capsule product for initial dosage, titration, and doses below 80 mg per day. ( 2.1 ) Administer Duloxetine Delayed-Release Capsules once daily on an empty stomach at least one hour before or two hours after a meal. Swallow whole, do not open, chew or crush. Do not sprinkle the capsule contents on food or mix with liquids. ( 2.1 ) MDD: Administer Duloxetine Delayed-Release Capsules in doses of 80 mg, 90 mg, or 120 mg. Periodically reassess for appropriate dosing. ( 2.2 ) GAD: Administer Duloxetine Delayed-Release Capsules in doses of 90 mg or 120 mg. Periodically reassess for appropriate dosing. ( 2.3 ) The maximum dosage is 120 mg once daily ( 2.2 , 2.3 ) When discontinuing treatment, reduce dose gradually whenever possible to avoid discontinuation symptoms. Gradual dosage reduction will require use of another duloxetine delayed-release capsule product. ( 2.6 ) 2.1 Important Administration Instructions Do not initiate treatment with Duloxetine Delayed-Release Capsules 80 mg, 90 mg, and 120 mg. Use another duloxetine delayed-release capsule product for initial dosage, titration, and doses below 80 mg per day. Refer to the Prescribing Information of other duloxetine delayed-release capsule products for the recommended dosage of those products. Administer Duloxetine Delayed-Release Capsules orally once daily on an empty stomach at least one hour before or two hours after a meal [see Pharmacokinetics ( 12.3 )] . Swallow whole and do not chew or crush. Do not open the delayed-release capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating. If a dose of Duloxetine Delayed-Release Capsules is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Duloxetine Delayed-Release Capsules at the same time. 2.2 Dosage for Treatment of Major Depressive Disorder Administer Duloxetine Delayed-Release Capsules in adults with MDD receiving at least 60 mg per day of another duloxetine delayed-release capsule product for one week [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . While duloxetine at a 120 mg per day dose was shown to be effective, there is no evidence that doses greater than 60 mg per day confer any additional benefits. Administer Duloxetine Delayed-Release Capsules once daily in doses of 80 mg, 90 mg, or 120 mg, titrating dose as tolerated when appropriate. Periodically reassess patients to determine the need for maintenance treatment and the appropriate dosage for such treatment. The maximum studied dosage is 120 mg once daily. 2.3 Dosage for Treatment of Generalized Anxiety Disorder Adults Less than 65 Years of Age with GAD Administer Duloxetine Delayed-Release Capsules in adults less than 65 years of age with GAD receiving at least 60 mg once daily of another duloxetine delayed-release capsule product for one week [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.2 )] . While duloxetine at a 120 mg once daily dosage was shown to be effective, there is no evidence that doses greater than 60 mg per day confer additional benefit. Nevertheless, if a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Administer Duloxetine Delayed-Release Capsules once daily in doses of 90 mg or 120 mg. Periodically reassess patients to determine the need for maintenance treatment and the appropriate dosage for such treatment. The maximum studied dosage is 120 mg once daily. Geriatric Patients with GAD Administer Duloxetine Delayed-Release Capsules in geriatric patients with GAD receiving at least 60 mg once daily of another duloxetine delayed-release capsule product for two weeks [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.2 )] . Patients may benefit from duloxetine dosages above 60 mg once daily. If a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Administer Duloxetine Delayed-Release Capsules once daily in doses of 90 mg or 120 mg. Periodically reassess patients to determine the need for maintenance treatment and the appropriate dosage for such treatment. The maximum studied dosage is 120 mg once daily. Pediatric Patients 7 to 17 years of Age with GAD Administer Duloxetine Delayed-Release Capsules in pediatric patients 7 to 17 years of age with GAD receiving at least 60 mg once daily of another duloxetine delayed-release capsule product for two weeks [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.2 )] . Some patients may benefit from duloxetine dosages above 60 mg once daily. If a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Administer Duloxetine Delayed-Release Capsules once daily in doses of 90 mg or 120 mg. Periodically reassess patients to determine the need for maintenance treatment and the appropriate dosage for such treatment. The maximum studied dosage is 120 mg once daily. 2.4 Dosage in Patients with Hepatic Impairment or Severe Renal Impairment Avoid use in patients with chronic liver disease or cirrhosis [see Warnings and Precautions ( 5.13 ), Use in Specific Populations ( 8.6 )] . Recommended dosage in patients with mild to moderate renal impairment (estimated creatinine clearance (CrCl) 30-80 mL/min; CrCl was estimated using Cockcroft-Gault method) is similar to that in patients with normal renal function. Avoid use in patients with severe renal impairment, estimated CrCl < 30 mL/minute [see Warnings and Precautions ( 5.13 ), Use in Specific Populations ( 8.7 )] .
Dosage forms and strengths
Duloxetine Delayed-Release Capsules are available as: 80 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque pale yellow cap and "821" printed axially on the opaque white body. Each capsule contains 89.8 mg of duloxetine hydrochloride, USP equivalent to 80 mg duloxetine. 90 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque green cap and "913" printed axially on the opaque white body. Each capsule contains 101 mg of duloxetine hydrochloride, USP equivalent to 90 mg duloxetine. 120 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque light green cap and "791" printed axially on the opaque white body. Each capsule contains 134.7 mg of duloxetine hydrochloride, USP equivalent to 120 mg duloxetine. Delayed-release capsules: 80 mg, 90 mg, and 120 mg ( 3 )
Contraindications
Duloxetine Delayed-Release Capsules are contraindicated in patients who are using or within 14 days of stopping an MAOI intended to treat psychiatric disorders because of an increased risk of serotonin syndrome. Allow at least 5 days after stopping Duloxetine Delayed-Release Capsules prior to initiation of an MAOI to treat psychiatric disorders. [see Dosage and Administration ( 2.7 ), Warnings and Precautions ( 5.4 )]. who are using other MAOIs such as linezolid or intravenous methylene blue because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.8 ), Warnings and Precautions ( 5.4 )]. Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 ) Do not start Duloxetine Delayed-Release Capsules in a patient who is being treated with linezolid or intravenous methylene blue ( 4 )
Warnings and precautions
Hepatotoxicity : Hepatic failure, sometimes fatal, has been reported. Discontinue Duloxetine Delayed-Release Capsules in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Avoid use in patients with substantial alcohol use or evidence of chronic liver disease. ( 5.2 ) Orthostatic Hypotension, Falls and Syncope : Consider dosage reduction or discontinuation if these events occur. ( 5.3 ) Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue Duloxetine Delayed-Release Capsules and serotonergic agents. ( 5.4 ) Increased Risk of Bleeding : May increase the risk of bleeding events. Concomitant use of antiplatelet drugs and anticoagulants may increase this risk. ( 5.5 , 7 , 8.1 ) Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur. Discontinue at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified. ( 5.6 ) Discontinuation Syndrome : Taper dose when possible and monitor for discontinuation symptoms. ( 5.7 ) Activation of Mania or Hypomania : Prior to initiating, screen patients for personal or family history of bipolar disorder, mania, or hypomania. ( 5.8 ) Angle-Closure Glaucoma : Has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.9 ) Seizures : Prescribe with care in patients with a history of seizure disorder. ( 5.10 ) Blood Pressure Increases : Monitor blood pressure prior to initiating treatment and periodically throughout treatment. ( 5.11 ) Hyponatremia : Can occur in association with SIADH; consider discontinuation. ( 5.12 ) Glucose Control in Diabetes : Worsened glycemic control has been observed. ( 5.13 ) Conditions that Slow Gastric Emptying : Use cautiously in these patients. ( 5.13 ) Sexual Dysfunction : Duloxetine Delayed-Release Capsules may cause symptoms of sexual dysfunction. ( 5.15 ) 5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in the antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18 to 24 5 additional patients Decreases Compared to Placebo 25 to 64 1 fewer patient ≥65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing Duloxetine Delayed-Release Capsules, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. 5.2 Hepatotoxicity There have been reports of hepatic failure, sometimes fatal, in patients treated with duloxetine. These cases have presented as hepatitis with abdominal pain, hepatomegaly, and elevation of transaminase levels to more than twenty times the upper limit of normal (ULN) with or without jaundice, reflecting a mixed or hepatocellular pattern of liver injury. Duloxetine Delayed-Release Capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Cases of cholestatic jaundice with minimal elevation of transaminase levels have also been reported. Other postmarketing reports indicate that elevated transaminases, bilirubin, and alkaline phosphatase have occurred in patients with chronic liver disease or cirrhosis. Duloxetine increased the risk of elevation of serum transaminase levels in development program clinical trials. Liver transaminase elevations resulted in the discontinuation of 0.3% (92/34,756) of duloxetine-treated patients. In most patients, the median time to detection of the transaminase elevation was about two months. In adult placebo-controlled trials, for patients with normal and abnormal baseline ALT values, elevation of ALT >3 times the ULN occurred in 1.25% (144/11,496) of duloxetine-treated patients compared to 0.45% (39/8,716) of placebo-treated patients.
Side effects
The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see Boxed Warning and Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions ( 5.3 )] Serotonin Syndrome [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Severe Skin Reactions [see Warnings and Precautions ( 5.6 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.7 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.8 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.9 )] Seizures [see Warnings and Precautions ( 5.10 )] Increases in Blood Pressure [see Warnings and Precautions ( 5.11 )] Hyponatremia [see Warnings and Precautions ( 5.12 )] Urinary Hesitation and Retention [see Warnings and Precautions ( 5.14 )] Sexual Dysfunction [see Warnings and Precautions ( 5.15 )] Most common adverse reactions (≥5% and at least twice the incidence of placebo-treated patients): ( 6.1 ) Adults : nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis Pediatric Patients : decreased weight, decreased appetite, nausea, vomiting, fatigue, and diarrhea To report SUSPECTED ADVERSE REACTIONS, contact Almatica Pharma LLC at 1-877-447-7979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Duloxetine Delayed-Release Capsules for the treatment for major depressive disorder (MDD) in adults and for the treatment of generalized anxiety disorder (GAD) in adults and pediatric patients is based upon adequate and well-controlled studies of another duloxetine delayed-release capsule product. The results of these adequate and well-controlled studies of duloxetine delayed-release capsules are presented below. The stated frequencies of adverse reactions represent the proportion of patients who experienced, at least once, one treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Adverse Reactions in Adults Adult Clinical Trial Database The data described below reflect exposure to duloxetine delayed-release capsules in placebo-controlled trials for MDD (N=3779), GAD (N=1018), and other indications (N=3303). The population studied was 17 years to 89 years of age. 66% and 61% were female, and 82% and 73% were Caucasian in the MDD and GAD populations, respectively. Most patients received duloxetine delayed-release capsules dosages of a total of 60 mg to 120 mg per day [see Clinical Studies ( 14.1 , 14.2 )] . The data below do not include results of the trial examining the efficacy of duloxetine delayed-release capsules in patients ≥ 65 years old for the treatment of generalized anxiety disorder; however, the adverse reactions observed in this geriatric sample were generally similar to adverse reactions in the overall adult population. Adverse Reactions Reported as Reasons for Discontinuation of Treatment in Adult Placebo-Controlled Trials Major Depressive Disorder Approximately 8.4% (319/3779) of the duloxetine delayed-release capsules-treated patients in placebo-controlled adult trials for MDD discontinued treatment due to an adverse reaction, compared with 4.6% (117/2536) of placebo-treated patients. Nausea (duloxetine delayed-release capsules 1.1%, placebo 0.4%) was the only adverse reaction reported as a reason for discontinuation and considered to be drug-related (i.e., discontinuation occurring in at least 1% of the duloxetine delayed-release capsules-treated patients and at a rate of at least twice that of placebo-treated patients). Generalized Anxiety Disorder Approximately 13.7% (139/1018) of the duloxetine delayed-release capsules-treated patients in placebo-controlled adult trials for GAD discontinued treatment due to an adverse reaction, compared with 5% (38/767) for placebo-treated patients. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (duloxetine delayed-release capsules 3.3%, placebo 0.4%), and dizziness (duloxetine delayed-release capsules 1.3%, placebo 0.4%). Adverse Reactions Occurring at an Incidence of 5% or More Among Duloxetine Delayed-Release Capsules Treated Patients in Adult Placebo-Controlled Trials The most commonly observed adverse reactions in duloxetine delayed-release capsule-treated patients (incidence of at least 5% and at least twice the incidence in placebo patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis. Table 2 displays the incidence of adverse reactions in placebo-controlled trials for approved indications that occurred in 5% or more of patients treated with duloxetine delayed-release capsules and with an incidence greater than placebo-treated patients. Table 2: Adverse Reactions: Incidence of 5% or More and Greater than Placebo in Placebo-Controlled Trials of Approved Adult Populations a a Includes adults with MDD, GAD, and other indications. The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer. b Also includes asthenia. c Events for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration. d Also includes initial insomnia, middle insomnia, and early morning awakening.
Drug interactions
Strong CYP1A2 inhibitors : Avoid concomitant use. ( 7.1 ) Potent inhibitors of CYP2D6 may increase Duloxetine Delayed-Release Capsule concentrations. ( 7.1 ) Duloxetine Delayed-Release Capsule is a moderate inhibitor of CYP2D6. ( 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Duloxetine Delayed-Release Capsules Table 6: Clinically Significant Drug Interactions with Duloxetine Delayed-Release Capsules Monoamine Oxidase Inhibitors (MAOIs) Prevention or Management Concomitant use of Duloxetine Delayed-Release Capsules is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.7 , 2.8 ), Contraindications ( 4 ), Warnings and Precautions ( 5.4 )] . Mechanism and Clinical Effect(s) Concomitant use of SSRIs and SNRIs, including Duloxetine Delayed-Release Capsules, with MAOIs increases the risk of serotonin syndrome. Other Serotonergic Drugs Prevention or Management Monitor for symptoms of serotonin syndrome when Duloxetine Delayed-Release Capsules is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of Duloxetine Delayed-Release Capsules and/or concomitant serotonergic drugs [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.4 )] . Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with other serotonergic drugs increases the risk of serotonin syndrome. Alcohol Prevention or Management Avoid use in patients with chronic liver disease or heavy alcohol use [see Warnings and Precautions ( 5.2 )] . Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules and alcohol may cause liver injury or aggravate pre-existing liver disease. Drugs that Interfere with Hemostasis Prevention or Management Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when Duloxetine Delayed-Release Capsules are initiated or discontinued [Warnings and Precaution ( 5.5 )] . Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. Strong CYP1A2 Inhibitors Prevention or Management Avoid concomitant use of Duloxetine Delayed-Release Capsules with strong CYP1A2 inhibitors [see Clinical Pharmacology ( 12.3 )]. Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with CYP1A2 inhibitors increase the exposures of duloxetine. Strong CYP2D6 Inhibitors Prevention or Management Monitor for adverse events and adjust the dose of Duloxetine Delayed-Release Capsules as clinically appropriate when co-administering with strong CYP2D6 inhibitors [see Clinical Pharmacology ( 12.3 )]. Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with CYP2D6 inhibitors increase the exposures of duloxetine. Greater degrees of inhibition are expected with higher doses of CYP2D6 inhibitors. CYP2D6 Poor Metabolizers Using Strong Inhibitor of CYP1A2 Prevention or Management Avoid co-administration of Duloxetine Delayed-Release Capsules and strong CYP1A2 inhibitors in patients who are CYP2D6 poor metabolizers [see Clinical Pharmacology ( 12.3 )] . Mechanism and Clinical Effect(s) Concomitant administration of Duloxetine Delayed-Release Capsules with strong CYP1A2 inhibitors in patients who are CYP2D6 poor metabolizers results in increased duloxetine exposures. Drugs Metabolized by CYP2D6 Prevention or Management Monitor plasma concentrations of CYP2D6 substrate and reduce dosage of CYP2D6 substrate drug if necessary [see Clinical Pharmacology ( 12.3 )] . Mechanism and Clinical Effect(s) Concomitant use of duloxetine increases exposures of a drug primarily metabolized by CYP2D6 which may increase the risk of toxicity of the CYP2D6 substrate drug. Drugs Metabolized by CYP1A2 Prevention or Management Monitor for adverse events and adjust the dose of Duloxetine Delayed-Release Capsules as clinically appropriate [see Clinical Pharmacology ( 12.3 )]. Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with CYP1A2 substrates may increase the exposures of CYP1A2 substrate. CNS Drugs Prevention or Management Monitor for adverse events and adjust the dose of Duloxetine Delayed-Release Capsules as clinically appropriate [see Clinical Pharmacology ( 12.3 )] . Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with other centrally acting drugs may increase the CNS effects of duloxetine. Drugs that Affect Gastric Acidity Prevention or Management Monitor for adverse events and adjust the dose of Duloxetine Delayed-Release Capsules as clinically appropriate [see Clinical Pharmacology ( 12.3 )]. Mechanism and Clinical Effect(s) In patients with conditions that may slow gastric emptying (e.g., some diabetics) and drugs that raise the gastrointestinal pH may lead to earlier the release of duloxetine. Drugs Highly Bound to Plasma Protein Prevention or Management Monitor for adverse events and adjust the dose of Duloxetine Delayed-Release Capsules as clinically appropriate [see Clinical Pharmacology ( 12.3 )]. Mechanism and Clinical Effect(s) Concomitant use of Duloxetine Delayed-Release Capsules with highly protein bound drugs may cause increased free concentrations of the other drug, potentially resulting in adverse reactions.
Use in specific populations
Pregnancy : Third trimester use may increase risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate. ( 8.1 ) Hepatic Impairment : Avoid use in patients with chronic liver disease or cirrhosis. ( 8.6 ) Renal Impairment : Avoid use in patients with severe renal impairment, GFR <30 mL/minute. ( 8.7 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors the pregnancy outcomes in women exposed to antidepressants, including Duloxetine Delayed-Release Capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes (see Data) . There are risks associated with untreated depression in pregnancy, and with exposure to SNRIs and SSRIs, including Duloxetine Delayed-Release Capsules, during pregnancy (see Clinical Considerations). In rats and rabbits treated with duloxetine during the period of organogenesis, fetal weights were decreased but there was no evidence of developmental effects at doses up to 3 times and 6 times, respectively, the maximum recommended human dose (MRHD) of 120 mg/day given to adolescents on a mg/m 2 basis. When duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the MRHD given to adolescents on a mg/m 2 basis. At this dose, pup behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity were observed. Post-weaning growth was not adversely affected. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of Duloxetine Delayed-Release Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.5 )]. Fetal/Neonatal Adverse Reaction Neonates exposed to duloxetine and other SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of the SNRIs or SSRIs, or possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions ( 5.4 )] . Data Human Data Data from a postmarketing retrospective claims-based cohort study found an increased risk for postpartum hemorrhage among 955 pregnant women exposed to duloxetine in the last month of pregnancy compared to 4,128,460 unexposed pregnant women (adjusted relative risk: 1.53; 95% CI: 1.08-2.18). The same study did not find a clinically meaningful increase in the risk for major birth defects in the comparison of 2,532 women exposed to duloxetine in the first trimester of pregnancy to 1,284,827 unexposed women after adjusting for several confounders. Methodologic limitations include possible residual confounding, misclassification of exposure and outcomes, lack of direct measures of disease severity, and lack of information about alcohol use, nutrition, and over-the-counter medication exposures. Animal Data In animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development. When duloxetine was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of malformations or developmental variations at doses up to 45 mg/kg/day [3 times and 6 times, respectively, the MRHD of 120 mg/day given to adolescents on a mg/m 2 basis]. However, fetal weights were decreased at this dose, with a no-effect dose of 10 mg/kg/day (approximately equal to the MRHD in rats and 2 times the MRHD in rabbits). When duloxetine was administered orally to pregnant rats throughout gestation and lactation, the survival of pups to 1 day postpartum and pup body weights at birth and during the lactation period were decreased at a dose of 30 mg/kg/day (2 times the MRHD given to adolescents on a mg/m 2 basis); the no-effect dose was 10 mg/kg/day.
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors the pregnancy outcomes in women exposed to antidepressants, including Duloxetine Delayed-Release Capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes (see Data) . There are risks associated with untreated depression in pregnancy, and with exposure to SNRIs and SSRIs, including Duloxetine Delayed-Release Capsules, during pregnancy (see Clinical Considerations). In rats and rabbits treated with duloxetine during the period of organogenesis, fetal weights were decreased but there was no evidence of developmental effects at doses up to 3 times and 6 times, respectively, the maximum recommended human dose (MRHD) of 120 mg/day given to adolescents on a mg/m 2 basis. When duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the MRHD given to adolescents on a mg/m 2 basis. At this dose, pup behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity were observed. Post-weaning growth was not adversely affected. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of Duloxetine Delayed-Release Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.5 )]. Fetal/Neonatal Adverse Reaction Neonates exposed to duloxetine and other SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of the SNRIs or SSRIs, or possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions ( 5.4 )] . Data Human Data Data from a postmarketing retrospective claims-based cohort study found an increased risk for postpartum hemorrhage among 955 pregnant women exposed to duloxetine in the last month of pregnancy compared to 4,128,460 unexposed pregnant women (adjusted relative risk: 1.53; 95% CI: 1.08-2.18). The same study did not find a clinically meaningful increase in the risk for major birth defects in the comparison of 2,532 women exposed to duloxetine in the first trimester of pregnancy to 1,284,827 unexposed women after adjusting for several confounders. Methodologic limitations include possible residual confounding, misclassification of exposure and outcomes, lack of direct measures of disease severity, and lack of information about alcohol use, nutrition, and over-the-counter medication exposures. Animal Data In animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development. When duloxetine was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of malformations or developmental variations at doses up to 45 mg/kg/day [3 times and 6 times, respectively, the MRHD of 120 mg/day given to adolescents on a mg/m 2 basis]. However, fetal weights were decreased at this dose, with a no-effect dose of 10 mg/kg/day (approximately equal to the MRHD in rats and 2 times the MRHD in rabbits). When duloxetine was administered orally to pregnant rats throughout gestation and lactation, the survival of pups to 1 day postpartum and pup body weights at birth and during the lactation period were decreased at a dose of 30 mg/kg/day (2 times the MRHD given to adolescents on a mg/m 2 basis); the no-effect dose was 10 mg/kg/day. Furthermore, behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity, were observed in pups following maternal exposure to 30 mg/kg/day. Post-weaning growth and reproductive performance of the progeny were not affected adversely by maternal duloxetine treatment.
Pediatric use
8.4 Pediatric Use Antidepressants increased the risk of suicidal thoughts and behavior in pediatric patients. Monitor all pediatric patients being treated with antidepressants for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of treatment, or at times of dosage changes [see Warnings and Precautions ( 5.1 )] . Perform regular monitoring of weight and growth in pediatric patients treated with Duloxetine Delayed-Release Capsules [see Adverse Reactions ( 6.1 )] . Generalized Anxiety Disorder The safety and effectiveness of Duloxetine Delayed-Release Capsules for the treatment of generalized anxiety disorder (GAD) in patients 7 years to 17 years of age is based upon an adequate and well‑controlled study of another duloxetine delayed-release capsule product. Use of Duloxetine Delayed-Release Capsules for this indication is supported by evidence from a single 10-week, placebo-controlled trial (Study 6) in 272 patients aged 7 to 17 years with GAD. Duloxetine delayed-release capsules demonstrated superiority over placebo as measured by greater improvement in the Pediatric Anxiety Rating Scale (PARS) for GAD severity score [see Clinical Studies ( 14.2 )]. The safety and effectiveness of Duloxetine Delayed-Release Capsules for the treatment of GAD have not been established in pediatric patients less than 7 years of age. Major Depressive Disorder The safety and effectiveness of Duloxetine Delayed-Release Capsules have not been established in pediatric patients for the treatment of MDD. Effectiveness was not demonstrated in two adequate and well controlled trials conducted in 800 pediatric patients aged 7 years to 17 years with MDD. Neither duloxetine delayed-release capsules nor an active control approved for treatment of pediatric MDD were superior to placebo in the 10-week trials. The most frequently observed adverse reactions in the MDD pediatric clinical trials included nausea, headache, decreased weight, and abdominal pain. Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. Juvenile Animal Toxicology Data Duloxetine administration to young rats from post-natal day 21 (weaning) through post-natal day 90 (adult) resulted in decreased body weights that persisted into adulthood, but recovered when drug treatment was discontinued; slightly delayed (~1.5 days) sexual maturation in females, without any effect on fertility; and a delay in learning a complex task in adulthood, which was not observed after drug treatment was discontinued. These effects were observed at the high dose of 45 mg/kg/day (2 times the MRHD, for a child); the no-effect-level was 20 mg/kg/day (≈1 times the MRHD, for a child).
Geriatric use
8.5 Geriatric Use Geriatric Exposure in Premarketing Clinical Trials of Duloxetine Of the 2,418 patients in MDD trials, 6% (143) were 65 years of age or over. In the MDD and GAD studies, no overall differences in safety or effectiveness were generally observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between these geriatric and younger adult patients, but greater sensitivity of some older patients cannot be ruled out. SSRIs and SNRIs, including Duloxetine Delayed-Release Capsules, have been associated with clinically significant hyponatremia in geriatric patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions ( 5.12 )] . In an analysis of data from all placebo-controlled trials, patients treated with duloxetine reported a higher rate of falls compared to placebo-treated patients. The increased risk appears to be proportional to a patient’s underlying risk for falls. Underlying risk appears to increase steadily with age. As geriatric patients tend to have a higher prevalence of risk factors for falls such as medications, medical comorbidities and gait disturbances, the impact of increasing age by itself on falls during duloxetine treatment is unclear. Falls with serious consequences including bone fractures and hospitalizations have been reported with duloxetine use [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . The pharmacokinetics of duloxetine after a single dose of 40 mg were compared in healthy elderly females (65 years to 77 years) and healthy middle-age females (32 years to 50 years). There was no difference in the C max , but the area under the concentration-time curve (AUC) of duloxetine was somewhat (about 25%) higher and the half-life about 4 hours longer in the elderly females. Population pharmacokinetic analyses suggest that the typical values for clearance decrease by approximately 1% for each year of age between 25 years to 75 years of age; but age as a predictive factor only accounts for a small percentage of between-patient variability. Dosage adjustment based on the age of the adult patient is not necessary.
Overdosage
10.1 Signs and Symptoms In postmarketing experience, fatal outcomes have been reported for acute duloxetine overdoses, primarily with mixed overdoses, but also with duloxetine only, including 1000 mg of duloxetine (approximately 8.3 times the maximum recommended dosage). Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting. 10.2 Management of Overdose There is no specific antidote to a duloxetine overdosage, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. In case of acute overdose with Duloxetine Delayed-Release Capsules, treatment should consist of those general measures employed in the management of overdose with any drug, such as assuring an adequate airway, oxygenation, and ventilation and monitoring cardiac rhythm and vital signs. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Induction of emesis is not recommended. Activated charcoal may be useful in limiting absorption of duloxetine from the gastrointestinal tract. Administration of activated charcoal has been shown to decrease duloxetine AUC and C max by an average of one-third, although some patients had a limited effect of activated charcoal. Due to the large volume of distribution of duloxetine, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be beneficial. In managing overdose, the possibility of multiple drug involvement should be considered. A specific caution involves patients who overdose with Duloxetine Delayed-Release Capsules and tricyclic antidepressants. In such a case, decreased clearance of the parent tricyclic and/or its active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation [see Warnings and Precautions ( 5.4 ), Drug Interactions ( 7 )] . Consider contacting a Poison Help line (1-800-222-1222 or www.poison.org) for additional information on the treatment of overdosage.
Description
Duloxetine Delayed-Release Capsules contain duloxetine hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-( S )-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C 18 H 19 NOS
• HCl, which corresponds to a molecular weight of 333.88. The structural formula is: Duloxetine hydrochloride is a white to brownish-white solid, which is slightly soluble in water. Duloxetine Delayed-Release Capsules are intended for oral administration. Each capsule contains enteric-coated pellets of 80 mg, 90 mg, or 120 mg of duloxetine (equivalent to 89.8 mg, 101 mg, or 134.7 mg of duloxetine hydrochloride, USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the enteric-coated pellets include colloidal silicon dioxide, cysteine, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, and triethyl citrate. The capsule shell ingredients for the 80 mg strength are D&C Yellow #10, gelatin, and titanium dioxide. The capsule shell ingredients for the 90 mg strength are D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, and titanium dioxide. The capsule shell ingredients for the 120 mg strength are D&C Yellow #10, FD&C Green #3, FD&C Red #40, gelatin, and titanium dioxide.
Mechanism of action
12.1 Mechanism of Action Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.
How supplied
How Supplied Duloxetine Delayed-Release Capsules are available as: 80 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque pale yellow cap and "821" printed axially on the opaque white body. Each capsule contains 89.8 mg of duloxetine hydrochloride, USP equivalent to 80 mg duloxetine. NDC 52427-821-30, bottle of 30 capsules with a child-resistant closure 90 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque green cap and "913" printed axially on the opaque white body. Each capsule contains 101 mg of duloxetine hydrochloride, USP equivalent to 90 mg duloxetine. NDC 52427-913-30, bottle of 30 capsules with a child-resistant closure 120 mg: Hard shell gelatin capsules, with "ALM" printed axially on the opaque light green cap and "791" printed axially on the opaque white body. Each capsule contains 134.7 mg of duloxetine hydrochloride, USP equivalent to 120 mg duloxetine. NDC 52427-791-30, bottle of 30 capsules with a child-resistant closure Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behaviors Advise patients, their families, and their caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1 )] . Administration Advise patients to take Duloxetine-Delayed Release Capsules on an empty stomach at least one hour before or two hours after a meal and to swallow Duloxetine Delayed-Release Capsules whole and to not chew, crush, or open the capsule (do not sprinkle contents on food or mixed with liquids) because these actions might affect the enteric coating. Hepatotoxicity Inform patients that severe liver problems, sometimes fatal, have been reported in patients treated with Duloxetine Delayed-Release Capsules. Instruct patients to talk to their healthcare provider immediately if they develop itching, right upper belly pain, dark urine, or yellow skin/eyes while taking Duloxetine Delayed-Release Capsules, which may be signs of liver problems. Instruct patients to talk to their healthcare provider about their alcohol consumption. Use of Duloxetine Delayed-Release Capsules with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions ( 5.2 )] . Alcohol Although Duloxetine Delayed-Release Capsules does not increase the impairment of mental and motor skills caused by alcohol, use of Duloxetine Delayed-Release Capsules concomitantly with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )] . Orthostatic Hypotension, Falls and Syncope Advise patients of the risk of orthostatic hypotension, falls and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of Duloxetine Delayed-Release Capsules [see Warnings and Precautions ( 5.3 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome with the concomitant use of Duloxetine Delayed-Release Capsules and other serotonergic agents including triptans, tricyclic antidepressants, opioids, lithium, buspirone, tryptophan, amphetamines, and St. John’s Wort [see Contraindications ( 4 ), Warnings and Precautions ( 5.4 ), Drug Interactions ( 7.1 )] . Advise patients of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Caution patients to seek medical care immediately if they experience these symptoms. Increased Risk of Bleeding Caution patients about the concomitant use of Duloxetine Delayed-Release Capsules and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.1 )] . Severe Skin Reactions Caution patients that Duloxetine Delayed-Release Capsules may cause serious skin reactions. This may need to be treated in a hospital and may be life-threatening. Counsel patients to call their doctor right away or get emergency help if they have skin blisters, peeling rash, sores in their mouth, hives, or any other allergic reactions [see Warnings and Precautions ( 5.6 )] . Discontinuation of Treatment Instruct patients that discontinuation of Duloxetine Delayed-Release Capsules may be associated with symptoms such as dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue, and should be advised not to alter their dosing regimen, or stop taking Duloxetine Delayed-Release Capsules without consulting their healthcare provider [see Warnings and Precautions ( 5.7 )] . Activation of Mania or Hypomania Adequately screen patients with depressive symptoms for risk of bipolar disorder (e.g. family history of suicide, bipolar disorder, and depression) prior to initiating treatment with Duloxetine Delayed-Release Capsules. Advise patients to report any signs or symptoms of a manic reaction such as greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, talking more or faster than usual, unusually grand ideas, and excessive happiness or irritability [see Warnings and Precautions ( 5.8 )] . Angle-Closure Glaucoma Advise patients that taking Duloxetine Delayed-Release Capsules can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions ( 5.9 )] . Seizures Advise patients to inform their healthcare provider if they have a history of seizure disorder [see Warnings and Precautions ( 5.10 )] . Effects on Blood Pressure Caution patients that Duloxetine Delayed-Release Capsules may cause an increase in blood pressure [see Warnings and Precautions ( 5.11 )] .
Label text from the FDA structured product label by Almatica Pharma LLC (revised Mar 2, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Duloxetine Hydrochloride in 180 products
Duloxetine NDC products (180)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-5940 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-6899 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-6900 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-7784 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-6893 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-6889 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | A-S Medication Solutions | ANDA |
| 50090-6775 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-6406 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-6281 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-7812 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 50090-7897 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 0228-2890 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Actavis Pharma, Inc. | ANDA |
| 0228-2892 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Actavis Pharma, Inc. | ANDA |
| 0228-2891 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Actavis Pharma, Inc. | ANDA |
| 80425-0389 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0441 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0119 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0311 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 27241-164 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release | Ajanta Pharma USA Inc. | ANDA |
| 27241-099 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Ajanta Pharma USA Inc. | ANDA |
| 27241-098 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Ajanta Pharma USA Inc. | ANDA |
| 27241-097 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Ajanta Pharma USA Inc. | ANDA |
| 70954-864 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | ANI Pharmaceuticals, Inc. | ANDA |
| 70954-861 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | ANI Pharmaceuticals, Inc. | ANDA |
| 70954-860 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | ANI Pharmaceuticals, Inc. | ANDA |
| 71610-402 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-218 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-401 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-403 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-736 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-739 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-743 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-954 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-957 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 67877-265 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Ascend Laboratories, LLC | ANDA |
| 67877-264 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Ascend Laboratories, LLC | ANDA |
| 67877-263 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Ascend Laboratories, LLC | ANDA |
| 87063-704 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release | ASCLEMED USA INC. | ANDA |
| 87063-702 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | ASCLEMED USA INC. | ANDA |
| 87063-703 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | ASCLEMED USA INC. | ANDA |
| 76420-634 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Asclemed USA, Inc. | ANDA |
| 76420-636 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release | Asclemed USA, Inc. | ANDA |
| 76420-633 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Asclemed USA, Inc. | ANDA |
| 76420-623 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Asclemed USA, Inc. | ANDA |
| 76420-236 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Asclemed USA, Inc. | ANDA |
| 59651-282 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Aurobindo Pharma Limited | ANDA |
| 59651-279 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Aurobindo Pharma Limited | ANDA |
| 59651-280 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Aurobindo Pharma Limited | ANDA |
| 68001-368 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release Pellets | BluePoint Laboratories | ANDA |
| 68001-570 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release | BluePoint Laboratories | ANDA |
| 68001-594 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | BluePoint Laboratories | ANDA |
| 68001-595 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | BluePoint Laboratories | ANDA |
| 68001-596 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | BluePoint Laboratories | ANDA |
| 51991-746 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Breckenridge Pharmaceutical, Inc. | ANDA |
| 51991-750 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release Pellets | Breckenridge Pharmaceutical, Inc. | ANDA |
| 51991-748 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Breckenridge Pharmaceutical, Inc. | ANDA |
| 51991-747 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Breckenridge Pharmaceutical, Inc. | ANDA |
| 63629-2063 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 63629-8748 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 63629-9187 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 63629-1991 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 72162-1058 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 72162-1597 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 72162-1598 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 72162-1600 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 72162-1599 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 71335-2625 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-0165 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 71335-0392 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 71335-0402 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-0509 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 71335-1445 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 71335-1672 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-1964 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-2017 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-2537 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-2567 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-2624 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Bryant Ranch Prepack | ANDA |
| 63629-1992 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 71335-3062 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Bryant Ranch Prepack | ANDA |
| 71335-3163 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Bryant Ranch Prepack | ANDA |
| 63629-1990 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Bryant Ranch Prepack | ANDA |
| 31722-170 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-168 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-169 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Camber Pharmaceuticals, Inc. | ANDA |
| 67046-1598 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Coupler LLC | ANDA |
| 67046-1585 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Coupler LLC | ANDA |
| 67046-1451 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Coupler LLC | ANDA |
| 51407-817 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Golden State Medical Supply, Inc. | ANDA |
| 51407-818 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Golden State Medical Supply, Inc. | ANDA |
| 51407-807 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-808 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-809 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-819 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Golden State Medical Supply, Inc. | ANDA |
| 51407-810 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Golden State Medical Supply, Inc. | ANDA |
| 85534-0017 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | HAWAII REPACK, INC | ANDA |
| 85534-0050 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | HAWAII REPACK, INC | ANDA |
| 85534-0051 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | HAWAII REPACK, INC | ANDA |
| 85534-0053 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release | HAWAII REPACK, INC. | ANDA |
| 85534-0016 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | HAWAII REPACK, INC. | ANDA |
| 85534-0018 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | HAWAII REPACK, INC. | ANDA |
| 85534-0052 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | HAWAII REPACK, INC. | ANDA |
| 49252-009 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Inventia Healthcare Limited. | ANDA |
| 49252-008 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Inventia Healthcare Limited. | ANDA |
| 49252-007 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Inventia Healthcare Limited. | ANDA |
| 68180-297 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-296 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-295 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-294 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Lupin Pharmaceuticals, Inc. | ANDA |
| 25000-608 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | MARKSANS PHARMA LIMITED | ANDA |
| 25000-609 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | MARKSANS PHARMA LIMITED | ANDA |
| 25000-610 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | MARKSANS PHARMA LIMITED | ANDA |
| 0615-8496 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8495 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8494 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 51655-237 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Northwind Health Company, LLC | ANDA |
| 68071-3766 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3775 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3979 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-2711 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3519 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3779 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | NuCare Pharmaceuticals,Inc. | ANDA |
| 72789-338 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-4026 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Preferred Phamaceuticals Inc. | ANDA |
| 68788-4025 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Preferred Phamaceuticals Inc. | ANDA |
| 68788-4128 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7897 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8782 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8623 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8608 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8362 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release Pellets | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7935 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7672 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Preferred Pharmaceuticals, Inc. | ANDA |
| 63187-702 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Proficient Rx LP | ANDA |
| 71205-602 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Proficient Rx LP | ANDA |
| 71205-525 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Proficient Rx LP | ANDA |
| 71205-445 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Proficient Rx LP | ANDA |
| 71205-358 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Proficient Rx LP | ANDA |
| 71205-005 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Proficient Rx LP | ANDA |
| 63187-720 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Proficient Rx LP | ANDA |
| 82804-024 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release Pellets | Proficient Rx LP | ANDA |
| 63187-666 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Proficient Rx LP | ANDA |
| 63187-612 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Proficient Rx LP | ANDA |
| 63187-735 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Proficient Rx LP | ANDA |
| 70247-012 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA |
| 70247-013 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA |
| 70247-014 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA |
| 42708-196 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | QPharma, Inc. | ANDA |
| 82009-171 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-170 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-172 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-173 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-030 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release Pellets | Quallent Pharmaceuticals Health, LLC | ANDA |
| 82009-031 | Duloxetine Hydrochloride 40 mg/1 Capsule, Delayed Release Pellets | Quallent Pharmaceuticals Health, LLC | ANDA |
| 82009-032 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | Quallent Pharmaceuticals Health, LLC | ANDA |
| 82009-029 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release Pellets | Quallent Pharmaceuticals Health, LLC | ANDA |
| 70518-3287 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | REMEDYREPACK INC. | ANDA |
| 70518-1139 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | REMEDYREPACK INC. | ANDA |
| 70518-1054 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | REMEDYREPACK INC. | ANDA |
| 70518-2630 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | REMEDYREPACK INC. | ANDA |
| 70518-1765 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | REMEDYREPACK INC. | ANDA |
| 70518-1244 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | REMEDYREPACK INC. | ANDA |
| 70518-4440 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | REMEDYREPACK INC. | ANDA |
| 70518-1011 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | REMEDYREPACK INC. | ANDA |
| 70518-0122 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release Pellets | REMEDYREPACK INC. | ANDA |
| 43547-379 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Solco Healthcare US, LLC | ANDA |
| 43547-380 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Solco Healthcare US, LLC | ANDA |
| 43547-381 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Solco Healthcare US, LLC | ANDA |
| 60760-461 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-462 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-759 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | St. Mary's Medical Park Pharmacy | ANDA |
| 47335-382 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Sun Pharmaceutical Industries, Inc. | ANDA |
| 47335-383 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Sun Pharmaceutical Industries, Inc. | ANDA |
| 47335-381 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Sun Pharmaceutical Industries, Inc. | ANDA |
| 65841-799 | Duloxetine Hydrochloride 20 mg/1 Capsule, Delayed Release | Zydus Lifesciences Limited | ANDA |
| 65841-801 | Duloxetine Hydrochloride 60 mg/1 Capsule, Delayed Release | Zydus Lifesciences Limited | ANDA |
| 65841-800 | Duloxetine Hydrochloride 30 mg/1 Capsule, Delayed Release | Zydus Lifesciences Limited | ANDA |
| 52427-913 | Duloxetine Hydrochloride 90 mg/1 Capsule, Delayed Release | Almatica Pharma LLC | NDA |
| 52427-821 | Duloxetine Hydrochloride 80 mg/1 Capsule, Delayed Release | Almatica Pharma LLC | NDA |
| 52427-791 | Duloxetine Hydrochloride 120 mg/1 Capsule, Delayed Release | Almatica Pharma LLC | NDA |
Duloxetine recalls
- D-0583-2026 Jun 17, 2026 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - D-0582-2026 Jun 17, 2026 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - D-0555-2026 Jun 10, 2026 · Class II · Ongoing
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. - D-0522-2026 May 13, 2026 · Class II · Ongoing
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - D-0516-2026 May 13, 2026 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. - D-0515-2026 May 13, 2026 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. - D-0514-2026 May 13, 2026 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. - D-0215-2026 Dec 10, 2025 · Class II · Ongoing
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - D-0216-2026 Dec 10, 2025 · Class II · Ongoing
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - D-0100-2026 Nov 5, 2025 · Class II · Ongoing
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. - D-0621-2025 Sep 17, 2025 · Class II · Ongoing
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. - D-0580-2025 Aug 20, 2025 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. - D-0552-2025 Aug 13, 2025 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit - D-0511-2025 Jul 16, 2025 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - D-0387-2025 Apr 30, 2025 · Class II · Ongoing
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. - D-0388-2025 Apr 30, 2025 · Class II · Ongoing
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. - D-0308-2025 Apr 9, 2025 · Class II · Ongoing
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. - D-0271-2025 Mar 19, 2025 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. - D-0270-2025 Mar 19, 2025 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. - D-0269-2025 Mar 19, 2025 · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Frequently asked questions
What is Duloxetine used for?
Duloxetine Delayed-Release Capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Duloxetine Delayed-Release Capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety…
What are the side effects of Duloxetine?
The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see Boxed Warning and Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions ( 5.3 )] Serotonin Syndrome [see Warnings and… See the full label for the complete list.
Who makes Duloxetine?
Duloxetine is listed by 41 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., Advanced Rx of Tennessee, LLC, Advanced Rx Pharmacy of Tennessee, LLC.
Has Duloxetine been recalled?
The FDA enforcement database lists 20 recalls for Duloxetine, most recently D-0583-2026 (class ii): CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit