Details for New Drug Application (NDA): 022502
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NDA 022502 describes DIFFERIN, which is a drug marketed by Galderma Labs Lp and is included in five NDAs. It is available from five suppliers. There are nine 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. Twenty-seven 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the adapalene profile page.
Summary for 022502
| Tradename: | DIFFERIN |
| Applicant: | Galderma Labs Lp |
| Ingredient: | adapalene |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 022502
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIFFERIN | adapalene | LOTION;TOPICAL | 022502 | NDA | Galderma Laboratories, L.P. | 0299-5912 | 0299-5912-01 | 15 mL in 1 BOTTLE (0299-5912-01) |
| DIFFERIN | adapalene | LOTION;TOPICAL | 022502 | NDA | Galderma Laboratories, L.P. | 0299-5912 | 0299-5912-02 | 1 BOTTLE, PUMP in 1 CARTON (0299-5912-02) / 59 mL in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Mar 17, 2010 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 31, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ACNE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 15, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ACNE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 15, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ACNE | ||||||||
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