Details for New Drug Application (NDA): 022212
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The generic ingredient in DUREZOL 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 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 | Novartis Pharmaceuticals Corporation | 0078-0862 | 0078-0862-25 | 1 BOTTLE in 1 CARTON (0078-0862-25) / 5 mL in 1 BOTTLE |
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 |
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 |
Expired US Patents for NDA 022212
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | DUREZOL | difluprednate | EMULSION;OPHTHALMIC | 022212-001 | Jun 23, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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