Details for New Drug Application (NDA): 021753
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The generic ingredient in DIFFERIN is adapalene. There are twelve drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the adapalene profile page.
Summary for 021753
| Tradename: | DIFFERIN |
| Applicant: | Galderma Labs Lp |
| Ingredient: | adapalene |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021753
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIFFERIN | adapalene | GEL;TOPICAL | 021753 | NDA | Galderma Laboratories, L.P. | 0299-5918 | 0299-5918-25 | 1 BOTTLE, PUMP in 1 CARTON (0299-5918-25) / 45 g in 1 BOTTLE, PUMP |
| DIFFERIN | adapalene | GEL;TOPICAL | 021753 | NDA AUTHORIZED GENERIC | Mayne Pharma Commercial LLC. | 68308-666 | 68308-666-25 | 1 TUBE in 1 CARTON (68308-666-25) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.3% | ||||
| Approval Date: | Jun 19, 2007 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021753
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ⤷ Get Started Free | ⤷ Get Started Free |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ⤷ Get Started Free | ⤷ Get Started Free |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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