Details for New Drug Application (NDA): 203981
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NDA 203981 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.
Suppliers and Packaging for NDA: 203981
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE | adapalene | SOLUTION;TOPICAL | 203981 | ANDA | CALL INC (d.b.a Rochester Pharmaceuticals) | 49908-117 | 49908-117-70 | 120 mL in 1 CARTON (49908-117-70) |
| ADAPALENE | adapalene | SOLUTION;TOPICAL | 203981 | ANDA | Allegis Holdings LLC | 71297-410 | 71297-410-02 | 1 BOTTLE, GLASS in 1 CARTON (71297-410-02) / 60 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Sep 23, 2016 | TE: | AB | RLD: | No | ||||
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