Details for New Drug Application (NDA): 209641
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NDA 209641 describes ADAPALENE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Labs Ut Inc, Actavis Mid Atlantic, Alembic, Encube, Glenmark Pharms Ltd, Padagis Israel, Taro, and Zydus Pharms, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the ADAPALENE AND BENZOYL PEROXIDE profile page.
The generic ingredient in ADAPALENE AND BENZOYL PEROXIDE 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 AND BENZOYL PEROXIDE 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 209641
| Tradename: | ADAPALENE AND BENZOYL PEROXIDE |
| Applicant: | Actavis Labs Ut Inc |
| Ingredient: | adapalene; benzoyl peroxide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209641
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 209641 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3154 | 0480-3154-45 | 1 BOTTLE, PUMP in 1 CARTON (0480-3154-45) / 45 g in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.3%;2.5% | ||||
| Approval Date: | Jun 22, 2022 | TE: | AB | RLD: | No | ||||
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