Details for New Drug Application (NDA): 200298
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NDA 200298 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.
Summary for 200298
| Tradename: | ADAPALENE |
| Applicant: | Encube Ethicals |
| Ingredient: | adapalene |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200298
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE | adapalene | GEL;TOPICAL | 200298 | ANDA | Encube Ethicals Private Limited | 21922-051 | 21922-051-06 | 1 TUBE in 1 CARTON (21922-051-06) / 45 g in 1 TUBE |
| ADAPALENE | adapalene | GEL;TOPICAL | 200298 | ANDA | Encube Ethicals Private Limited | 21922-051 | 21922-051-50 | 1 BOTTLE, PUMP in 1 CARTON (21922-051-50) / 45 g in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.3% | ||||
| Approval Date: | Jun 14, 2012 | TE: | AB | RLD: | No | ||||
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