NDC 47335-507 – Cequa
Cyclosporine .0009 mg/mL · Solution/ Drops · Ophthalmic, Topical
Product NDC47335-507
Product details
- Brand name
- Cequa
- Generic name
- Cyclosporine
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Dosage form
- Solution/ Drops
- Route
- Ophthalmic, Topical
- Marketing category
- NDA · NDA210913
- Marketed since
- August 15, 2018
- Listing expires
- December 31, 2027
- Pharmacologic class
- Calcineurin Inhibitor Immunosuppressant
Active ingredients
- Cyclosporine .0009 mg/mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 47335-507-97 sample | 1 POUCH in 1 BOX (47335-507-97) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE | Aug 15, 2018 |
Recalls mentioning this NDC
- D-1172-2023 Sep 27, 2023 · Class III
Subpotent: Out of Specification result observed for low assay - D-0770-2022 Apr 13, 2022 · Class III
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter. - D-0391-2021 May 26, 2021 · Class III
Subpotent and Presence of Particulates . - D-0289-2021 Mar 10, 2021 · Class III
Subpotent
Other Cequa products
- 47335-506 Cyclosporine .0009 g/mL · Solution/ Drops · Sun Pharmaceutical Industries, Inc.