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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Boehringer Ingelheim
Fish and Richardson
Queensland Health

Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019832

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NDA 019832 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 three 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 NDA: 019832

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 019832

Ingredient-typeMethylated Sulfonamides

Suppliers and Packaging for NDA: 019832

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)

Summary for product number 003

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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Cantor Fitzgerald
Johnson and Johnson
US Army
US Department of Justice

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