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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020428

Marketing Status: Prescription
Active Ingredient: AZELAIC ACID
Proprietary Name: AZELEX
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 20%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020428
Product Number: 001
Approval Date: Sep 13, 1995
Applicant Holder Full Name: ALMIRALL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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