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Last Updated: November 13, 2024

Details for New Drug Application (NDA): 206716


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NDA 206716 describes MAFENIDE ACETATE, which is a drug marketed by Endo Operations and Novast Labs and is included in two NDAs. It is available from two suppliers. Additional details are available on the MAFENIDE ACETATE profile page.

The generic ingredient in MAFENIDE ACETATE 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 206716
Tradename:MAFENIDE ACETATE
Applicant:Novast Labs
Ingredient:mafenide acetate
Patents:0
Pharmacology for NDA: 206716
Medical Subject Heading (MeSH) Categories for 206716
Suppliers and Packaging for NDA: 206716
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAFENIDE ACETATE mafenide acetate FOR SOLUTION;TOPICAL 206716 ANDA Ingenus Pharmaceuticals, LLC 50742-310 50742-310-25 5 PACKET in 1 CARTON (50742-310-25) / 1 POWDER, FOR SOLUTION in 1 PACKET (50742-310-50)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;TOPICALStrength5%
Approval Date:Jul 31, 2017TE:RLD:No

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