Details for New Drug Application (NDA): 090824
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NDA 090824 describes ADAPALENE, which is a drug marketed by Fougera Pharms, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Pharms Inc, P And L, Taro, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, and Zydus Pharms, and is included in twenty NDAs. It is available from thirty-six suppliers. Additional details are available on the ADAPALENE profile page.
The generic ingredient in ADAPALENE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
The generic ingredient in ADAPALENE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
Summary for 090824
| Tradename: | ADAPALENE |
| Applicant: | Fougera Pharms |
| Ingredient: | adapalene |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090824
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE | adapalene | CREAM;TOPICAL | 090824 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0424 | 0168-0424-46 | 1 TUBE in 1 CARTON (0168-0424-46) / 45 g in 1 TUBE |
| ADAPALENE | adapalene | CREAM;TOPICAL | 090824 | ANDA | Bryant Ranch Prepack | 63629-8791 | 63629-8791-1 | 1 TUBE in 1 CARTON (63629-8791-1) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Jun 30, 2010 | TE: | AB | RLD: | No | ||||
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