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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212464

ADAPALENE AND BENZOYL PEROXIDE (ADAPALENE; BENZOYL PEROXIDE)
0.3%;2.5%
Marketing Status: Prescription
Active Ingredient: ADAPALENE; BENZOYL PEROXIDE
Proprietary Name: ADAPALENE AND BENZOYL PEROXIDE
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.3%;2.5%
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212464
Product Number: 001
Approval Date: May 31, 2022
Applicant Holder Full Name: PADAGIS ISRAEL PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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