Details for New Drug Application (NDA): 208108
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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 208108
Tradename: | ADAPALENE AND BENZOYL PEROXIDE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | adapalene; benzoyl peroxide |
Patents: | 0 |
Suppliers and Packaging for NDA: 208108
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 208108 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-301 | 68462-301-47 | 1 BOTTLE, PUMP in 1 CARTON (68462-301-47) / 45 g in 1 BOTTLE, PUMP |
ADAPALENE AND BENZOYL PEROXIDE | adapalene; benzoyl peroxide | GEL;TOPICAL | 208108 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-301 | 68462-301-55 | 45 g in 1 TUBE (68462-301-55) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.1%;2.5% | ||||
Approval Date: | Nov 8, 2019 | TE: | AB | RLD: | No |
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