Pentamidine Injectable Solution

Brand(s)
Pentam
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2012-03-07)
Oldest Current Product
2001-01-16
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\PENTAMIDINE
FDAOB
INJECTION\INJECTION\PENTAMIDINE ISETHIONATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PENTAMIDINE ISETHIONATE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PENTAMIDINE

product(s) by strength(s)

pentamidine isethionate 100 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230113PentamNDAApp Pharmaceuticals, Llc2001-01-16PENTAMIDINE ISETHIONATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA019264cc2b635e-4840-4dc3-a177-5484371680e8

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA073447PENTACARINATTrueARMOUR PHARMACEUTICAL CO1994-04-28ANDA073447_001
2ANDA073479PENTAMIDINE ISETHIONATETrueHOSPIRA INC1992-06-30ANDA073479_001
3ANDA073617PENTAMIDINE ISETHIONATETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1995-12-18ANDA073617_001
4ANDA074303PENTAMIDINE ISETHIONATETrueWATSON LABORATORIES INC1995-08-17ANDA074303_001
5NDA019264PENTAMFRESENIUS KABI USA LLC1984-10-16NDA019264_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA073447_001discontinuedPENTAMIDINE ISETHIONATE (300MG/VIAL)INJECTIONFalse1994-04-28PENTACARINAT
2ANDA073479_001discontinuedPENTAMIDINE ISETHIONATE (300MG/VIAL)INJECTIONFalse1992-06-30PENTAMIDINE ISETHIONATE
3ANDA073617_001discontinuedPENTAMIDINE ISETHIONATE (300MG/VIAL)INJECTIONFalse1995-12-18PENTAMIDINE ISETHIONATE
4ANDA074303_001discontinuedPENTAMIDINE ISETHIONATE (300MG/VIAL)INJECTIONFalse1995-08-17PENTAMIDINE ISETHIONATE
5NDA019264_001RXPENTAMIDINE ISETHIONATE (300MG/VIAL)INJECTIONTrue1984-10-16PENTAM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1cc2b635e-4840-4dc3-a177-5484371680e8 (view SPL)Pentam 300 (pentamidine isethionate for injection)prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-03-071633230113

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