Details for New Drug Application (NDA): 217384
NDA 217384 describes ADAPALENE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Labs Ut Inc, Actavis Mid Atlantic, Alembic, Aurobindo Pharma Ltd, Encube, Glenmark Pharms Ltd, Padagis Israel, Sun Pharma Canada, and Zydus Pharms, and is included in eleven NDAs. It is available from eleven 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 is one drug master file entry 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 is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
Summary for 217384
| Tradename: | ADAPALENE AND BENZOYL PEROXIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | adapalene; benzoyl peroxide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217384
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 217384 | ANDA | Aurobindo Pharma Limited | 59651-604 | 59651-604-46 | 1 BOTTLE, PUMP in 1 CARTON (59651-604-46) / 45 g in 1 BOTTLE, PUMP |
| ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 217384 | ANDA | Aurobindo Pharma Limited | 59651-604 | 59651-604-60 | 1 BOTTLE, PUMP in 1 CARTON (59651-604-60) / 60 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: | Jul 22, 2026 | TE: | AB | RLD: | No | ||||
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