Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020380

0.1% Marketing Status: Over-the-counter

Active Ingredient: ADAPALENE
Proprietary Name: DIFFERIN
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020380
Product Number: 002
Approval Date: Jul 8, 2016
Applicant Holder Full Name: GALDERMA LABORATORIES LP
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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