Details for New Drug Application (NDA): 216935
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NDA 216935 describes PREDNISOLONE ACETATE, which is a drug marketed by Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, and Lupin Ltd, and is included in ten NDAs. It is available from one supplier. Additional details are available on the PREDNISOLONE ACETATE profile page.
The generic ingredient in PREDNISOLONE ACETATE is prednisolone acetate. There are eighty-eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.
The generic ingredient in PREDNISOLONE ACETATE is prednisolone acetate. There are eighty-eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.
Summary for 216935
| Tradename: | PREDNISOLONE ACETATE |
| Applicant: | Lupin Ltd |
| Ingredient: | prednisolone acetate |
| Patents: | 0 |
Pharmacology for NDA: 216935
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 216935
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREDNISOLONE ACETATE | prednisolone acetate | SUSPENSION/DROPS;OPHTHALMIC | 216935 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-332 | 70748-332-02 | 1 BOTTLE in 1 CARTON (70748-332-02) / 5 mL in 1 BOTTLE |
| PREDNISOLONE ACETATE | prednisolone acetate | SUSPENSION/DROPS;OPHTHALMIC | 216935 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-332 | 70748-332-03 | 1 BOTTLE in 1 CARTON (70748-332-03) / 10 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Aug 2, 2024 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 9, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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