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Serving leading biopharmaceutical companies globally:

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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201511

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NDA 201511 describes MAFENIDE ACETATE, which is a drug marketed by Novast Labs Ltd and Par Form 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 201511
Applicant:Par Form
Ingredient:mafenide acetate
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 201511
Ingredient-typeMethylated Sulfonamides
Medical Subject Heading (MeSH) Categories for 201511
Suppliers and Packaging for NDA: 201511
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAFENIDE ACETATE mafenide acetate FOR SOLUTION;TOPICAL 201511 ANDA Par Pharmaceutical, Inc. 49884-902 49884-902-52 1 CARTON in 1 PACKET (49884-902-52) > 5 POWDER, FOR SOLUTION in 1 CARTON (49884-902-78)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;TOPICALStrength5%
Approval Date:Feb 12, 2013TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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