Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016763

Marketing Status: Prescription
Active Ingredient: MAFENIDE ACETATE
Proprietary Name: SULFAMYLON
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: EQ 85MG BASE/GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N016763
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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