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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207917

EPIDUO FORTE (ADAPALENE; BENZOYL PEROXIDE)
0.3%;2.5%
Marketing Status: Prescription
Active Ingredient: ADAPALENE; BENZOYL PEROXIDE
Proprietary Name: EPIDUO FORTE
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.3%;2.5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N207917
Product Number: 001
Approval Date: Jul 15, 2015
Applicant Holder Full Name: GALDERMA LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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