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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021470

Marketing Status: Prescription
Active Ingredient: AZELAIC ACID
Proprietary Name: FINACEA
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 15%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021470
Product Number: 001
Approval Date: Dec 24, 2002
Applicant Holder Full Name: LEO PHARMA AS
Marketing Status:  Prescription
Patent and Exclusivity Information
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