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Last Updated: May 24, 2024

Details for New Drug Application (NDA): 016763


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NDA 016763 describes SULFAMYLON, which is a drug marketed by Rising and Mylan Institutional and is included in two NDAs. It is available from one supplier. Additional details are available on the SULFAMYLON profile page.

The generic ingredient in SULFAMYLON is mafenide acetate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mafenide acetate profile page.
Summary for 016763
Tradename:SULFAMYLON
Applicant:Rising
Ingredient:mafenide acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 016763
Medical Subject Heading (MeSH) Categories for 016763
Suppliers and Packaging for NDA: 016763
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFAMYLON mafenide acetate CREAM;TOPICAL 016763 NDA Rising Pharma Holdings, Inc. 16571-723 16571-723-12 1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE
SULFAMYLON mafenide acetate CREAM;TOPICAL 016763 NDA Rising Pharma Holdings, Inc. 16571-723 16571-723-48 453.6 g in 1 JAR (16571-723-48)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 85MG BASE/GM
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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