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Last Updated: July 8, 2020

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Details for New Drug Application (NDA): 019832

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NDA 019832 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 019832
Applicant:Mylan Institutional
Ingredient:mafenide acetate
Formulation / Manufacturing:see details
Pharmacology for NDA: 019832
Medical Subject Heading (MeSH) Categories for 019832
Suppliers and Packaging for NDA: 019832
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFAMYLON mafenide acetate FOR SOLUTION;TOPICAL 019832 NDA Mylan Institutional Inc. 51079-624 51079-624-85 5 PACKET in 1 CARTON (51079-624-85) > 1 POWDER, FOR SOLUTION in 1 PACKET (51079-624-84)

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;TOPICALStrength5%
Approval Date:Jun 5, 1998TE:ATRLD:Yes

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