Gentamicin Sulfate (USP) Topical Ointment

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Perrigo New York Inc (2014-10-23)
Oldest Current Product
2006-07-10
License(s)
ANDA
RxNORM
TOPICAL OINTMENT\GENTAMICIN SULFATE (USP)
FDAOB
TOPICAL\OINTMENT\GENTAMICIN SULFATE
SPL Active
TOPICAL\OINTMENT\GENTAMICIN
TOPICAL\OINTMENT\GENTAMICIN SULFATE
SPL Moiety
TOPICAL\OINTMENT\GENTAMICIN

product(s) by strength(s)

gentamicin sulfate (usp) 0.001 mg/mg topical ointment

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001680078ANDAE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2010-03-17GENTAMICINTOPICALOINTMENTANDA062533f986fa2a-e667-452f-be4c-bad8588af525
2458020046ANDAPerrigo New York Inc2006-07-10GENTAMICIN SULFATETOPICALOINTMENTANDA062351a9486ae1-350b-41c5-ae0c-a4d692bb2dfd

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545691144ANDAA-S Medication Solutions Llc2010-03-17GENTAMICINTOPICALOINTMENT001680078ANDA062533388451a0-c4fa-4a19-9d33-8152cfe37eb7
2548686126ANDAPhysicians Total Care, Inc.2010-06-02GENTAMICIN SULFATETOPICALOINTMENT001680078ANDA06253378d87bc5-be86-4429-8ca3-e0a883108f9b

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060463GARAMYCINTrueSCHERING CORP SUB SCHERING PLOUGH CORPANDA060463_001
2ANDA062351GENTAMICIN SULFATEPERRIGO NEW YORK INC1982-02-18ANDA062351_001
3ANDA062444GENTAFAIRTruePHARMAFAIR INC1983-05-26ANDA062444_001
4ANDA062477GENTAMICIN SULFATETARO PHARMACEUTICALS USA INC1983-12-23ANDA062477_001
5ANDA062496GENTAMICIN SULFATETrueALPHARMA US PHARMACEUTICALS DIVISION1984-03-14ANDA062496_001
6ANDA062533GENTAMICIN SULFATEE FOUGERA DIV ALTANA INC1984-10-05ANDA062533_001
7ANDA062534GENTAMICIN SULFATETruePHARMADERM DIV ALTANA INC1984-10-10ANDA062534_001
8ANDA064054GENTAMICIN SULFATETrueG AND W LABORATORIES INC1994-04-29ANDA064054_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060463_001discontinuedGENTAMICIN SULFATE (EQ 0.1% BASE)TOPICALOINTMENTFalseGARAMYCIN
2ANDA062351_001RXGENTAMICIN SULFATE (EQ 0.1% BASE)TOPICALOINTMENTTrueAT1982-02-18GENTAMICIN SULFATE
3ANDA062444_001discontinuedGENTAMICIN SULFATE (EQ 0.1% BASE)TOPICALOINTMENTFalse1983-05-26GENTAFAIR
4ANDA062477_001RXGENTAMICIN SULFATE (EQ 0.1% BASE)TOPICALOINTMENTFalseAT1983-12-23GENTAMICIN SULFATE
5ANDA062496_001discontinuedGENTAMICIN SULFATE (EQ 0.1% BASE)TOPICALOINTMENTFalse1984-03-14GENTAMICIN SULFATE
6ANDA062533_001RXGENTAMICIN SULFATE (EQ 0.1% BASE)TOPICALOINTMENTFalseAT1984-10-05GENTAMICIN SULFATE
7ANDA062534_001discontinuedGENTAMICIN SULFATE (EQ 0.1% BASE)TOPICALOINTMENTFalse1984-10-10GENTAMICIN SULFATE
8ANDA064054_001discontinuedGENTAMICIN SULFATE (EQ 0.1% BASE)TOPICALOINTMENTFalse1994-04-29GENTAMICIN SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1388451a0-c4fa-4a19-9d33-8152cfe37eb7 (view SPL)GENTAMICIN SULFATE OINTMENT USP, 0.1%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691144
278d87bc5-be86-4429-8ca3-e0a883108f9b (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-06-072548686126
3a9486ae1-350b-41c5-ae0c-a4d692bb2dfd (view SPL)Gentamicin Sulfate Ointment USP, 0.1%prescriptionHuman PrescriptionPerrigo New York Inc2014-10-235458020046
4f986fa2a-e667-452f-be4c-bad8588af525 (view SPL)GENTAMICIN SULFATE OINTMENT USP, 0.1%prescriptionHuman PrescriptionE. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.2014-02-053001680078

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