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Details for New Drug Application (NDA): 201511

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NDA 201511 describes MAFENIDE ACETATE, which is a drug marketed by Par Form and is included in one NDA. It is available from one supplier. Additional details are available on the MAFENIDE ACETATE profile page.

The generic ingredient in MAFENIDE ACETATE is mafenide acetate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mafenide acetate profile page.

Summary for NDA: 201511

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 201511

Ingredient-typeMethylated Sulfonamides

Suppliers and Packaging for NDA: 201511

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

Summary for product number 001

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.