Details for New Drug Application (NDA): 212464
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NDA 212464 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 212464
| Tradename: | ADAPALENE AND BENZOYL PEROXIDE |
| Applicant: | Padagis Israel |
| Ingredient: | adapalene; benzoyl peroxide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212464
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 212464 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-853 | 45802-853-45 | 45 g in 1 BOTTLE, PUMP (45802-853-45) |
| ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 212464 | ANDA | Bryant Ranch Prepack | 63629-9322 | 63629-9322-1 | 45 g in 1 BOTTLE, PUMP (63629-9322-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.3%;2.5% | ||||
| Approval Date: | May 31, 2022 | TE: | AB | RLD: | No | ||||
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