Gentamicin Sulfate (USP) Ophthalmic Solution

Brand(s)
Garamycin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2013-06-20)
Oldest Current Product
1984-10-10
License(s)
ANDA
RxNORM
OPHTHALMIC SOLUTION\GENTAMICIN SULFATE (USP)
FDAOB
OPHTHALMIC\SOLUTION_DROPS\GENTAMICIN SULFATE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\GENTAMICIN SULFATE
OPHTHALMIC\SOLUTION\GENTAMICIN SULFATE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\GENTAMICIN
OPHTHALMIC\SOLUTION\GENTAMICIN

product(s) by strength(s)

gentamicin sulfate (usp) 3 mg/ml ophthalmic solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005744072GaramycinANDAPaddock Laboratories, Llc2014-06-05GENTAMICIN SULFATEOPHTHALMICSOLUTIONANDA065121c4dafa35-2e51-4c24-9516-f5c8b716e091
2174780283ANDAAkorn2006-12-13GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPSANDA064163877ab1fd-6c0e-42f6-9522-f5efaa96018d
3174780826ANDAAkorn2013-03-11GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPSANDA06416332d5af97-70bd-4ee4-81d4-67578dc677a0
4242080580ANDABausch & Lomb Incorporated1994-05-11GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPSANDA06404841d01350-5c4b-42fc-be5f-986ceec02bd3
5481020022GaramycinANDAFera Pharmaceuticals2011-05-15GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPSANDA065121aa2b006d-f67c-4c71-abce-55d55295b5bb
6607580188ANDAPacific Pharma, Inc.1998-01-05GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPSANDA0624520bc9fa00-1755-4989-a222-a038e970371f
7613140633ANDASandoz Inc1996-04-05GENTAMICIN SULFATEOPHTHALMICSOLUTIONANDA062196a213fb9c-08ea-4f30-a6c9-93c7a9ba5280

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950187ANDARebel Distributors Corp1984-10-10GENTAMICIN SULFATEOPHTHALMICSOLUTION607580188ANDA062452d7a27e38-0553-4d4b-8438-fed235e9b989
2332610604ANDAAidarex Pharmaceuticals Llc1998-01-05GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS607580188ANDA0624522e647e36-15d9-49e9-b81b-35465441e37a
3353560707ANDALake Erie Medical Dba Quality Care Products Llc1998-01-05GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS607580188ANDA062452c868d3fb-0a00-445b-a40d-bd0627293815
4458650672ANDAMedsource Pharmaceuticals1994-05-11GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS242080580ANDA0640481f908b73-d829-4c6f-e054-00144ff8d46c
5499990138ANDALake Erie Medical Dba Quality Care Products Llc2012-03-12GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS242080580ANDA0640485106f179-0413-41c7-b93f-786b0d515129
6504366752ANDAUnit Dose Services1994-05-11GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS242080580ANDA064048c3a08907-778d-4229-9f72-20cc4f57b10c
7521250461ANDARemedyrepack Inc.2013-07-05, 2013-12-05GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS607580188ANDA0624524687a0ea-4dd3-4e7b-9124-b65c3aef3485, 9245b639-cd83-4868-b96a-d343b48496bd
8545691218ANDAA-S Medication Solutions Llc1994-05-11GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS242080580ANDA064048b0a2b7af-85f1-4e49-a270-ca69e9fd539c
9548686745ANDAPhysicians Total Care, Inc.1993-09-17GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS242080580ANDA064048fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d
10581189893ANDAClinical Solutions Wholesale1994-05-11GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS242080580ANDA064048e1256852-fbe7-441e-8d39-1c78c9805ddb
11619190106ANDADirect Rx2014-01-01GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS607580188ANDA06245251a411a0-2671-4c1c-bf25-e29b32efed0c
12631870163ANDAProficient Rx Lp1998-01-05GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS607580188ANDA0624523ab508ed-4b12-4dd7-a13e-1a071f560286
13631870560ANDAProficient Rx Lp1994-05-11GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS242080580ANDA0640483a6677a6-def5-443e-82bc-c185d41f03b7
14687880633ANDAPreferred Pharmaceuticals, Inc.2013-03-14GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS242080580ANDA064048c5fac820-18a1-452f-bc2c-58ed73babb0c
15687889921ANDAPreferred Pharmaceuticals, Inc.2014-03-25GENTAMICIN SULFATEOPHTHALMICSOLUTION/DROPS607580188ANDA0624526a8e95ad-0a33-4d97-b44c-57555ccdf83a

application(s)

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

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
3ANDA062452_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT1984-10-10GENOPTIC
4ANDA062480_001discontinuedGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalse1984-03-30GENTACIDIN
5ANDA062523_001discontinuedGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalse1985-11-25GENTAMICIN SULFATE
6ANDA062635_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT1987-01-08GENTAMICIN SULFATE
7ANDA062932_001discontinuedGENTAMICIN SULFATE (EQ 3MG BASE/ML)OPHTHALMICSOLUTION/DROPSFalse1988-11-07GENTAMICIN SULFATE
8ANDA064048_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSTrueAT1994-05-11GENTAMICIN SULFATE
9ANDA064163_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2001-10-12GENTAK
10ANDA065121_001RXGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2004-01-30GENTAMICIN SULFATE
11NDA050039_002discontinuedGENTAMICIN SULFATE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseGARAMYCIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10bc9fa00-1755-4989-a222-a038e970371f (view SPL)GENTAMICIN SULFATEophthalmic solution, USP 0.3%sterileprescriptionHuman PrescriptionPacific Pharma, Inc.MANUFACTURE2013-08-314607580188
21f908b73-d829-4c6f-e054-00144ff8d46c (view SPL)Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)prescriptionHuman PrescriptionMedsource Pharmaceuticalsrelabel2015-09-121458650672
32e647e36-15d9-49e9-b81b-35465441e37a (view SPL)GENTAMICIN SULFATEophthalmic solution, USP 0.3%sterileprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-031332610604
432d5af97-70bd-4ee4-81d4-67578dc677a0 (view SPL)Gentamicin Sulfate Ophthalmic SolutionUSP,0.3%SterileprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-03-081174780826
53a6677a6-def5-443e-82bc-c185d41f03b7 (view SPL)Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870560
63ab508ed-4b12-4dd7-a13e-1a071f560286 (view SPL)GENTAMICIN SULFATE ophthalmic solution, USP 0.3% sterileprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-09-011631870163
741d01350-5c4b-42fc-be5f-986ceec02bd3 (view SPL)Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2013-06-205242080580
84687a0ea-4dd3-4e7b-9124-b65c3aef3485 (view SPL)GENTAMICIN SULFATEOphthalmic Solution, USP 0.3%prescriptionHuman PrescriptionRemedyrepack Inc.2013-12-051521250461
95106f179-0413-41c7-b93f-786b0d515129 (view SPL)Gentamicin SulfateOphthalmic Solution USP, 0.3% (Sterile)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, relabel2012-03-133642499990138
1051a411a0-2671-4c1c-bf25-e29b32efed0c (view SPL)gentamicin sulfateprescriptionHuman PrescriptionDirect Rxrelabel2015-01-021619190106
116a8e95ad-0a33-4d97-b44c-57555ccdf83a (view SPL)GENTAMICIN SULFATE ophthalmic solution, USP 0.3% sterileprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-03-252687889921
12877ab1fd-6c0e-42f6-9522-f5efaa96018d (view SPL)Gentamicin Sulfate Ophthalmic Solution USP, 0.3%prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2012-08-102174780283
139245b639-cd83-4868-b96a-d343b48496bd (view SPL)GENTAMICIN SULFATEOphthalmic Solution, USP 0.3%prescriptionHuman PrescriptionRemedyrepack Inc.2013-07-051521250461
14a213fb9c-08ea-4f30-a6c9-93c7a9ba5280 (view SPL)Gentamicin Sulfate Ophthalmic Solution USPprescriptionHuman PrescriptionSandoz Inc2014-08-274613140633
15aa2b006d-f67c-4c71-abce-55d55295b5bb (view SPL)prescriptionHuman PrescriptionFera Pharmaceuticals2011-04-261481020022
16b0a2b7af-85f1-4e49-a270-ca69e9fd539c (view SPL)Gentamicin SulfateOphthalmic Solution USP, 0.3% (Sterile)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691218
17c3a08907-778d-4229-9f72-20cc4f57b10c (view SPL)Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)prescriptionHuman PrescriptionUnit Dose ServicesREPACK2013-06-202504366752
18c4dafa35-2e51-4c24-9516-f5c8b716e091 (view SPL)Garamycin gentamicin sulfate ophthalmic solution USP, 0.3%prescriptionHuman PrescriptionPaddock Laboratories, Llc2014-07-212005744072
19c5fac820-18a1-452f-bc2c-58ed73babb0c (view SPL)Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-03-252687880633
20c868d3fb-0a00-445b-a40d-bd0627293815 (view SPL)GENTAMICIN SULFATEOphthalmic Solution, USP 0.3%prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-06-283884353560707
21d7a27e38-0553-4d4b-8438-fed235e9b989 (view SPL)GENTAMICIN SULFATEOphthalmic Solution, USP 0.3%prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-271216950187
22e1256852-fbe7-441e-8d39-1c78c9805ddb (view SPL)Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL2013-12-161581189893
23fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d (view SPL)Gentamicin SulfateOphthalmic Solution USP, 0.3% (Sterile)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-02-273548686745

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