Gentamicin Sulfate (USP) Ophthalmic Ointment

Brand(s)
Garamycin, Gentak
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2013-03-08)
Oldest Current Product
1994-09-21
License(s)
ANDA
RxNORM
OPHTHALMIC OINTMENT\GENTAMICIN SULFATE (USP)
FDAOB
OPHTHALMIC\OINTMENT\GENTAMICIN SULFATE
OPHTHALMIC\SOLUTION_DROPS\GENTAMICIN SULFATE
SPL Active
OPHTHALMIC\OINTMENT\GENTAMICIN SULFATE
SPL Moiety
OPHTHALMIC\OINTMENT\GENTAMICIN

product(s) by strength(s)

gentamicin sulfate (usp) 0.003 mg/mg ophthalmic ointment

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005744102ANDAPaddock Laboratories, Llc2013-12-12GENTAMICIN SULFATEOPHTHALMICOINTMENTANDA065024b24f76fa-8bac-460b-a916-f51ce6713b3e
2139850603ANDAMwi2015-03-23GENTAMICIN SULFATEOPHTHALMICOINTMENTANDA06416383851d99-d526-4a8b-b375-a3034bf3957a
3174780284GentakANDAAkorn2006-05-08GENTAMICIN SULFATEOPHTHALMICOINTMENTANDA064093a357d23d-1f10-44ce-a2fa-a6a5e03e7739
4174780827GentakANDAAkorn2013-03-11GENTAMICIN SULFATEOPHTHALMICOINTMENTANDA064093561cf436-74b8-452c-9fd2-e42f859c87dd
5481020009GaramycinANDAFera Pharmaceuticals2010-10-08GENTAMICIN SULFATEOPHTHALMICOINTMENTANDA065024eed34897-8455-4556-bfe6-eedb08ff54cd
6481020102ANDAFera Pharmaceuticals2011-01-03GENTAMICIN SULFATEOPHTHALMICOINTMENTANDA0650245e8da3cb-9156-4d46-a35a-96fe326e238d

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1499990159GentakANDALake Erie Medical Dba Quality Care Products Llc2012-03-27GENTAMICIN SULFATEOPHTHALMICOINTMENT174780284ANDA064093a10572d0-ed48-4bf2-87d3-cdc626ce00bf
2521250296GentakANDARemedyrepack Inc.2013-06-24GENTAMICIN SULFATEOPHTHALMICOINTMENT174780284ANDA06409314c27962-ac00-40f1-acbb-760fcbba880b
3545691229GentakANDAA-S Medication Solutions Llc2006-05-08GENTAMICIN SULFATEOPHTHALMICOINTMENT174780284ANDA0640935c7bd65f-9273-4684-a89a-e985a81fe8fd
4548681040ANDAPhysicians Total Care, Inc.1994-09-21GENTAMICIN SULFATEOPHTHALMICOINTMENT001680044ANDA065024cb21d1fd-4158-4be8-943d-176c1552f0dd
5687889732GentakANDAPreferred Pharmaceuticals, Inc.2012-10-23GENTAMICIN SULFATEOPHTHALMICOINTMENT174780284ANDA064093d1f5095e-199a-4be8-a1fb-7c01c5054ff9

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA062196GENTAMICIN SULFATEALCON RESEARCH LTDANDA062196_001Gentamicin Sulfate (USP) Ophthalmic Solution
2ANDA062440GENTAFAIRTruePHARMAFAIR INC1983-05-03ANDA062440_001Gentamicin Sulfate (USP) Ophthalmic Solution
3ANDA062443GENTAFAIRTruePHARMAFAIR INC1983-05-26ANDA062443_001
4ANDA062452GENOPTICALLERGAN1984-10-10ANDA062452_001Gentamicin Sulfate (USP) Ophthalmic Solution
5ANDA062480GENTACIDINTrueNOVARTIS PHARMACEUTICALS CORP1984-03-30ANDA062480_001Gentamicin Sulfate (USP) Ophthalmic Solution
6ANDA062501GENTACIDINTrueNOVARTIS PHARMACEUTICALS CORP1984-07-26ANDA062501_001
7ANDA062523GENTAMICIN SULFATETrueALCON PHARMACEUTICALS LTD1985-11-25ANDA062523_001Gentamicin Sulfate (USP) Ophthalmic Solution
8ANDA062635GENTAMICIN SULFATEAKORN INC1987-01-08ANDA062635_001Gentamicin Sulfate (USP) Ophthalmic Solution
9ANDA062932GENTAMICIN SULFATETruePACO RESEARCH CORP1988-11-07ANDA062932_001Gentamicin Sulfate (USP) Ophthalmic Solution
10ANDA064048GENTAMICIN SULFATEBAUSCH AND LOMB PHARMACEUTICALS INC1994-05-11ANDA064048_001Gentamicin Sulfate (USP) Ophthalmic Solution
11ANDA064093GENTAMICIN SULFATEAKORN INC1995-08-31ANDA064093_001
12ANDA064163GENTAKAKORN INC2001-10-12ANDA064163_001Gentamicin Sulfate (USP) Ophthalmic Solution
13ANDA065024GENTAMICIN SULFATEPERRIGO CO TENNESSEE INC2004-07-30ANDA065024_001
14ANDA065121GENTAMICIN SULFATEPERRIGO CO TENNESSEE INC2004-01-30ANDA065121_001Gentamicin Sulfate (USP) Ophthalmic Solution
15NDA050039GARAMYCINTrueSCHERING CORP SUB SCHERING PLOUGH CORPNDA050039_002Gentamicin Sulfate (USP) Ophthalmic Solution
16NDA050425GARAMYCINTrueSCHERING CORP SUB SCHERING PLOUGH CORPNDA050425_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062196_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseATGENTAMICIN SULFATE
2ANDA062440_001discontinuedGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalse1983-05-03GENTAFAIR
3ANDA062443_001discontinuedGENTAMICIN SULFATE (EQ 3MG BASE/GM)OPHTHALMICOINTMENTFalse1983-05-26GENTAFAIR
4ANDA062452_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT1984-10-10GENOPTIC
5ANDA062480_001discontinuedGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalse1984-03-30GENTACIDIN
6ANDA062501_001discontinuedGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICOINTMENTFalse1984-07-26GENTACIDIN
7ANDA062523_001discontinuedGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalse1985-11-25GENTAMICIN SULFATE
8ANDA062635_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT1987-01-08GENTAMICIN SULFATE
9ANDA062932_001discontinuedGENTAMICIN SULFATE (EQ 3MG BASE/ML)OPHTHALMICSOLUTION/DROPSFalse1988-11-07GENTAMICIN SULFATE
10ANDA064048_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSTrueAT1994-05-11GENTAMICIN SULFATE
11ANDA064093_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICOINTMENTTrueAT1995-08-31GENTAMICIN SULFATE
12ANDA064163_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2001-10-12GENTAK
13ANDA065024_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICOINTMENTFalseAT2004-07-30GENTAMICIN SULFATE
14ANDA065121_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2004-01-30GENTAMICIN SULFATE
15NDA050039_002discontinuedGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseGARAMYCIN
16NDA050425_001discontinuedGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICOINTMENTFalseGARAMYCIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
114c27962-ac00-40f1-acbb-760fcbba880b (view SPL)GENTAKGentamicin SulfateOphthalmic Ointment USP,03%prescriptionHuman PrescriptionRemedyrepack Inc.2013-06-241521250296
2561cf436-74b8-452c-9fd2-e42f859c87dd (view SPL)GENTAK Gentamicin SulfateOphthalmic Ointment USP, 0.3%SterileprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-03-081174780827
35c7bd65f-9273-4684-a89a-e985a81fe8fd (view SPL)GENTAK Gentamicin SulfateOphthalmic Ointment USP,03%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691229
45e8da3cb-9156-4d46-a35a-96fe326e238d (view SPL)Gentamicin Sulfate Ophthalmic Ointment, USP Sterile Rx OnlyprescriptionHuman PrescriptionFera Pharmaceuticals2011-01-052481020102
583851d99-d526-4a8b-b375-a3034bf3957a (view SPL)apexaGentamicin SulfateprescriptionHuman PrescriptionMwiANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-03-231139850603
6a10572d0-ed48-4bf2-87d3-cdc626ce00bf (view SPL)GENTAK Gentamicin SulfateOphthalmic Ointment USP,03%prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-10-175000499990159
7a357d23d-1f10-44ce-a2fa-a6a5e03e7739 (view SPL)GENTAK Gentamicin SulfateOphthalmic Ointment USP,03%prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2012-03-021174780284
8b24f76fa-8bac-460b-a916-f51ce6713b3e (view SPL)Gentamicin Sulfate Ophthalmic Ointment USPprescriptionHuman PrescriptionPaddock Laboratories, Llc2013-12-161005744102
9cb21d1fd-4158-4be8-943d-176c1552f0dd (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-06-071548681040
10d1f5095e-199a-4be8-a1fb-7c01c5054ff9 (view SPL)GENTAK Gentamicin SulfateOphthalmic Ointment USP,03%prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2012-10-231687889732
11eed34897-8455-4556-bfe6-eedb08ff54cd (view SPL)Garamycin brand of Gentamicin Sulfate Ophthalmic Ointment, USP Sterile Rx OnlyprescriptionHuman PrescriptionFera Pharmaceuticals2010-09-242481020009

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