Details for New Drug Application (NDA): 091314
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NDA 091314 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 091314
| Tradename: | ADAPALENE |
| Applicant: | Glenmark Pharms Inc |
| Ingredient: | adapalene |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091314
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE | adapalene | GEL;TOPICAL | 091314 | ANDA | Walgreens | 0363-0888 | 0363-0888-05 | 1 TUBE in 1 CARTON (0363-0888-05) / 15 g in 1 TUBE |
| ADAPALENE | adapalene | GEL;TOPICAL | 091314 | ANDA | Walgreens | 0363-0888 | 0363-0888-16 | 1 TUBE in 1 CARTON (0363-0888-16) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | GEL;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Jul 1, 2010 | TE: | RLD: | No | |||||
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