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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208011

AZELAIC ACID (AZELAIC ACID)
15%
Marketing Status: Prescription
Active Ingredient: AZELAIC ACID
Proprietary Name: AZELAIC ACID
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 15%
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208011
Product Number: 001
Approval Date: Nov 19, 2018
Applicant Holder Full Name: ACTAVIS LABORATORIES UT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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