Details for New Drug Application (NDA): 213508
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NDA 213508 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: 213508
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE | adapalene | GEL;TOPICAL | 213508 | ANDA | Alembic Pharmaceuticals Inc. | 62332-549 | 62332-549-15 | 1 TUBE in 1 CARTON (62332-549-15) / 15 g in 1 TUBE |
| ADAPALENE | adapalene | GEL;TOPICAL | 213508 | ANDA | Alembic Pharmaceuticals Inc. | 62332-549 | 62332-549-45 | 1 TUBE in 1 CARTON (62332-549-45) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.3% | ||||
| Approval Date: | Jun 18, 2020 | TE: | AB | RLD: | No | ||||
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