Details for New Drug Application (NDA): 020380
NDA 020380 describes DIFFERIN, which is a drug marketed by Galderma Labs Lp and is included in six NDAs. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DIFFERIN profile page.
The generic ingredient in DIFFERIN is adapalene; benzoyl peroxide. There are two 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 DIFFERIN is adapalene; benzoyl peroxide. There are two 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 020380
| Tradename: | DIFFERIN |
| Applicant: | Galderma Labs Lp |
| Ingredient: | adapalene |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020380
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIFFERIN | adapalene | GEL;TOPICAL | 020380 | NDA | Galderma Laboratories, L.P. | 0299-4910 | 0299-4910-00 | 1 TUBE in 1 BLISTER PACK (0299-4910-00) / 2 g in 1 TUBE |
| DIFFERIN | adapalene | GEL;TOPICAL | 020380 | NDA | Galderma Laboratories, L.P. | 0299-4910 | 0299-4910-10 | 1 BOTTLE, PUMP in 1 CARTON (0299-4910-10) / 15 g in 1 BOTTLE, PUMP |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | GEL;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Jul 8, 2016 | TE: | RLD: | Yes | |||||
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