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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim
Cantor Fitzgerald
Federal Trade Commission

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016763

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NDA 016763 describes SULFAMYLON, which is a drug marketed by 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
Applicant:Mylan Institutional
Ingredient:mafenide acetate
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 016763
Ingredient-typeMethylated Sulfonamides
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 Mylan Institutional Inc. 51079-623 51079-623-83 6 JAR in 1 BOX (51079-623-83) > 453.6 g in 1 JAR
SULFAMYLON mafenide acetate CREAM;TOPICAL 016763 NDA Mylan Institutional Inc. 51079-623 51079-623-81 1 TUBE in 1 CARTON (51079-623-81) > 56.7 g in 1 TUBE

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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Serving leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
Daiichi Sankyo
Boehringer Ingelheim

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