Details for New Drug Application (NDA): 211526
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The generic ingredient in DIFLUPREDNATE is difluprednate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the difluprednate profile page.
Summary for 211526
Tradename: | DIFLUPREDNATE |
Applicant: | Amneal |
Ingredient: | difluprednate |
Patents: | 0 |
Suppliers and Packaging for NDA: 211526
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DIFLUPREDNATE | difluprednate | EMULSION;OPHTHALMIC | 211526 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1380 | 69238-1380-3 | 1 BOTTLE in 1 CARTON (69238-1380-3) / 5 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;OPHTHALMIC | Strength | 0.05% | ||||
Approval Date: | Nov 17, 2021 | TE: | AB | RLD: | No |
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