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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091314

ADAPALENE (ADAPALENE)
0.1%
Marketing Status: Over-the-counter
Active Ingredient: ADAPALENE
Proprietary Name: ADAPALENE
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.1%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091314
Product Number: 001
Approval Date: Jul 1, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS INC USA
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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