Mafenide Topical Solution

Brand(s)
Sulfamylon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Institutional Inc. (2012-06-05)
Oldest Current Product
1998-06-05
License(s)
NDA, ANDA
RxNORM
TOPICAL SOLUTION\MAFENIDE
FDAOB
TOPICAL\FOR SOLUTION\MAFENIDE ACETATE
SPL Active
TOPICAL\POWDER, FOR SOLUTION\MAFENIDE ACETATE
SPL Moiety
TOPICAL\POWDER, FOR SOLUTION\MAFENIDE

product(s) by strength(s)

mafenide 50 mg/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1510790624SulfamylonNDAMylan Institutional Inc.1998-06-05MAFENIDE ACETATETOPICALPOWDER, FOR SOLUTIONNDA019832570ce479-d902-4394-bbae-41dfe16c5485

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840902ANDAPar Pharmaceutical Companies, Inc.2013-02-12MAFENIDE ACETATETOPICALPOWDER, FOR SOLUTIONANDA201511e48cc935-2058-48c0-9281-b8b919629493

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA201511MAFENIDE ACETATEPAR FORMULATIONS PRIVATE LTD2013-02-12ANDA201511_001
2NDA019832SULFAMYLONMYLAN INSTITUTIONAL INC1998-06-05NDA019832_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201511_001RXMAFENIDE ACETATE (5%)TOPICALFOR SOLUTIONFalseAT2013-02-12MAFENIDE ACETATE
2NDA019832_003RXMAFENIDE ACETATE (5%)TOPICALFOR SOLUTIONTrueAT1998-06-05SULFAMYLON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1570ce479-d902-4394-bbae-41dfe16c5485 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2012-06-055510790624
2e48cc935-2058-48c0-9281-b8b919629493 (view SPL)STERILERx onlyprescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.ANALYSIS, MANUFACTURE2015-02-094498840902

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII