Details for New Drug Application (NDA): 022212
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NDA 022212 describes DUREZOL, which is a drug marketed by Sandoz and is included in one NDA. It is available from one supplier. Additional details are available on the DUREZOL profile page.
The generic ingredient in DUREZOL is difluprednate. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the difluprednate profile page.
The generic ingredient in DUREZOL is difluprednate. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the difluprednate profile page.
Summary for 022212
| Tradename: | DUREZOL |
| Applicant: | Sandoz |
| Ingredient: | difluprednate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 022212
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DUREZOL | difluprednate | EMULSION;OPHTHALMIC | 022212 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-6000 | 0781-6000-78 | 1 BOTTLE in 1 CARTON (0781-6000-78) / 5 mL in 1 BOTTLE |
| DUREZOL | difluprednate | EMULSION;OPHTHALMIC | 022212 | NDA | Sandoz Inc | 66758-086 | 66758-086-75 | 1 BOTTLE in 1 CARTON (66758-086-75) / 5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;OPHTHALMIC | Strength | 0.05% | ||||
| Approval Date: | Jun 23, 2008 | TE: | AB | RLD: | Yes | ||||
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