Details for New Drug Application (NDA): 020380
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NDA 020380 describes DIFFERIN, which is a drug marketed by Galderma Labs Lp and is included in five NDAs. It is available from four suppliers. There are four 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. There are twelve drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the adapalene profile page.
The generic ingredient in DIFFERIN is adapalene. There are twelve drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the adapalene 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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