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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 seven 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 eleven drug master file entries for this compound. Seventeen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the adapalene profile page.

Summary for NDA: 020380

Tradename:
DIFFERIN
Applicant:
Galderma Labs Lp
Ingredient:
adapalene
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020380

Ingredient-typeRetinoids

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 0299-4910-15 1 TUBE in 1 CARTON (0299-4910-15) > 15 g in 1 TUBE
DIFFERIN
adapalene
GEL;TOPICAL 020380 NDA Galderma Laboratories, L.P. 0299-4910 0299-4910-45 1 TUBE in 1 CARTON (0299-4910-45) > 45 g in 1 TUBE

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:GEL;TOPICALStrength0.1%
Approval Date:Jul 8, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 8, 2019
Regulatory Exclusivity Use:RX TO OTC SWITCH OR OTC USE


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