Details for New Drug Application (NDA): 215940
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NDA 215940 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.
Suppliers and Packaging for NDA: 215940
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADAPALENE | adapalene | GEL;TOPICAL | 215940 | ANDA | CROWN LABORATORIES | 0316-0143 | 0316-0143-15 | 1 TUBE in 1 CARTON (0316-0143-15) / 15 g in 1 TUBE |
| ADAPALENE | adapalene | GEL;TOPICAL | 215940 | ANDA | RUGBY LABORATORIES, INC. | 0536-1412 | 0536-1412-20 | 1 TUBE in 1 CARTON (0536-1412-20) / 15 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | GEL;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Jan 14, 2022 | TE: | RLD: | No | |||||
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