Details for New Drug Application (NDA): 214553
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NDA 214553 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 214553
| Tradename: | ADAPALENE AND BENZOYL PEROXIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | adapalene; benzoyl peroxide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214553
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 214553 | ANDA | Zydus Lifesciences Limited | 70771-1716 | 70771-1716-3 | 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-3) / 60 g in 1 BOTTLE, PUMP |
| ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 214553 | ANDA | Zydus Lifesciences Limited | 70771-1716 | 70771-1716-4 | 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (70771-1716-4) / 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 3, 2022 | TE: | AB | RLD: | No | ||||
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