Details for New Drug Application (NDA): 216935
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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 |
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