Gentamicin Sulfate (USP) Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-07-03)
Oldest Current Product
1982-03-04
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\GENTAMICIN SULFATE (USP)
FDAOB
INJECTION\INJECTION\GENTAMICIN SULFATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION, CONCENTRATE\GENTAMICIN SULFATE
INTRAMUSCULAR\INJECTION, SOLUTION\GENTAMICIN SULFATE
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\GENTAMICIN SULFATE
INTRAVENOUS\INJECTION, SOLUTION\GENTAMICIN SULFATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION, CONCENTRATE\GENTAMICIN
INTRAMUSCULAR\INJECTION, SOLUTION\GENTAMICIN
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\GENTAMICIN
INTRAVENOUS\INJECTION, SOLUTION\GENTAMICIN

product(s) by strength(s)

gentamicin sulfate (usp) 0.6 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1003380501ANDABaxter Healthcare Corporation1982-09-072010-11-05GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA062373449c9a41-d61e-49fd-b5e3-d76f74b92acf

gentamicin sulfate (usp) 0.8 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003380503ANDABaxter Healthcare Corporation1982-09-07GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA062373449c9a41-d61e-49fd-b5e3-d76f74b92acf
2004097884ANDAHospira, Inc.2009-12-04GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA0624142fcd1c1f-bd01-42c7-2c89-5eee2fe7055b

gentamicin sulfate (usp) 0.9 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004097886ANDAHospira, Inc.2009-12-04GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA0624142fcd1c1f-bd01-42c7-2c89-5eee2fe7055b

gentamicin sulfate (usp) 1 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003380505ANDABaxter Healthcare Corporation1982-09-07GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA062373449c9a41-d61e-49fd-b5e3-d76f74b92acf
2004097889ANDAHospira, Inc.2009-12-04GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA0624142fcd1c1f-bd01-42c7-2c89-5eee2fe7055b

gentamicin sulfate (usp) 1.2 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003380507ANDABaxter Healthcare Corporation1982-09-07GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA062373449c9a41-d61e-49fd-b5e3-d76f74b92acf
2004097879ANDAHospira, Inc.2009-12-04GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA0624142fcd1c1f-bd01-42c7-2c89-5eee2fe7055b

gentamicin sulfate (usp) 1.4 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004097881ANDAHospira, Inc.2009-12-04GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA0624142fcd1c1f-bd01-42c7-2c89-5eee2fe7055b

gentamicin sulfate (usp) 1.6 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003380509ANDABaxter Healthcare Corporation1982-09-07GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA062373449c9a41-d61e-49fd-b5e3-d76f74b92acf
2004097883ANDAHospira, Inc.2009-12-04GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA0624142fcd1c1f-bd01-42c7-2c89-5eee2fe7055b

gentamicin sulfate (usp) 10 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093400ANDAHospira, Inc.2011-11-30GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA0626124f35bd00-b600-4972-6cba-ea5702f7d9bc
2004093401ANDAHospira, Inc.2011-11-30GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA0626124f35bd00-b600-4972-6cba-ea5702f7d9bc
3004093402ANDAHospira, Inc.2011-11-30GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA0626124f35bd00-b600-4972-6cba-ea5702f7d9bc
4633230173ANDAApp Pharmaceuticals, Llc2004-11-29GENTAMICIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA06236663413469-c676-48a3-a945-7d2489b535ef, 8bdeef7f-ad8e-46e0-a872-e945eae51d68, be5b414e-d598-4721-80ee-5836156ad210

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551549552ANDACardinal Health1982-03-04GENTAMICIN SULFATEINTRAMUSCULARINJECTION, SOLUTION633230513ANDA062356df42df85-1ce1-41e8-876f-40d4a8c8b67d
2633230513ANDAApp Pharmaceuticals, Llc1982-03-04GENTAMICIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA062356ca625340-377b-4256-92e2-d62471a8d852

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551549376ANDACardinal Health2004-11-29GENTAMICIN SULFATEINTRAMUSCULARINJECTION, SOLUTION633230173ANDA062366faa12ba9-072d-465e-9753-4ab4f1e3b6c6

gentamicin sulfate (usp) 2 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003380511ANDABaxter Healthcare Corporation1982-09-07GENTAMICIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA062373449c9a41-d61e-49fd-b5e3-d76f74b92acf

gentamicin sulfate (usp) 40 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091207ANDAHospira, Inc.1983-08-08, 2014-07-01GENTAMICIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA062420977180b3-a222-4282-d485-4a3217674305, bb2e10d2-1500-4dde-8281-8ab44abf28f0
2633230010ANDAApp Pharmaceuticals, Llc2000-08-10GENTAMICIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA0623660cce2238-28d3-4280-b520-ffc3067a2ffa, 84f5c763-1cd3-4d85-9afb-934db8666fbf, a73a5453-c091-43fd-aae2-d992152363b1

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840010ANDAGeneral Injecatables & Vaccines, Inc2010-09-01GENTAMICIN SULFATEINTRAMUSCULARINJECTION, SOLUTION633230010ANDA0623668104ee83-6e67-4e61-8cb2-854fc72cd87d
2525840207ANDAGeneral Injecatables & Vaccines, Inc2010-08-01GENTAMICIN SULFATEINTRAMUSCULARINJECTION, SOLUTION, CONCENTRATE004091207ANDA0624201bf429e3-6e0c-4244-ba1a-af1a3a153c24
3551542392ANDACardinal Health1983-08-15GENTAMICIN SULFATEINTRAMUSCULARINJECTION, SOLUTION, CONCENTRATE004091207ANDA0624205113bfad-42ca-4bb8-9343-0b08c6cd03f0
4551549365ANDACardinal Health2000-08-10GENTAMICIN SULFATEINTRAMUSCULARINJECTION, SOLUTION633230010ANDA0623661dd0d718-2ca7-4371-b726-5d67a2673fdf

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA061716GARAMYCINTrueSCHERING CORP SUB SCHERING PLOUGH CORPANDA061716_001, ANDA061716_002
2ANDA061739GARAMYCINTrueSCHERING CORP SUB SCHERING PLOUGH CORPANDA061739_001
3ANDA062248U-GENCINTruePHARMACIA AND UPJOHN COANDA062248_001, ANDA062248_002
4ANDA062251GENTAMICIN SULFATETrueHIKMA MAPLE LTDANDA062251_001, ANDA062251_002
5ANDA062264GENTAMICIN SULFATETrueWYETH AYERST LABORATORIESANDA062264_001, ANDA062264_002
6ANDA062288BRISTAGENTrueBRISTOL LABORATORIES INC DIV BRISTOL MYERS COANDA062288_001
7ANDA062289APOGENTrueKING PHARMACEUTICALS INCANDA062289_001, ANDA062289_002
8ANDA062318GENTAMICIN SULFATETrueWATSON LABORATORIES INCANDA062318_001, ANDA062318_002
9ANDA062325GENTAMICINTrueINTERNATIONAL MEDICATION SYSTEMS LTDANDA062325_001, ANDA062325_003, ANDA062325_004
10ANDA062340GENTAMICIN SULFATETruePHARMACEUTICAL SPECIALIST ASSOC1983-03-28ANDA062340_001
11ANDA062354GENTAMICIN SULFATETrueKALAPHARM INC1982-04-05ANDA062354_001
12ANDA062356GENTAMICIN SULFATETrueFRESENIUS KABI USA LLC1982-03-04ANDA062356_001, ANDA062356_002
13ANDA062366GENTAMICIN SULFATEFRESENIUS KABI USA LLC1983-08-04ANDA062366_001, ANDA062366_002
14ANDA062373ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1982-09-07ANDA062373_001, ANDA062373_002, ANDA062373_003, ANDA062373_004, ANDA062373_005, ANDA062373_006, ANDA062373_007, ANDA062373_008, ANDA062373_009, ANDA062373_010
15ANDA062413GENTAMICIN SULFATETrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV1983-08-11ANDA062413_001, ANDA062413_002, ANDA062413_003, ANDA062413_004, ANDA062413_005, ANDA062413_006, ANDA062413_007, ANDA062413_008, ANDA062413_009, ANDA062413_010
16ANDA062414GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHOSPIRA INC1983-08-15ANDA062414_001, ANDA062414_002, ANDA062414_003, ANDA062414_004, ANDA062414_005, ANDA062414_006, ANDA062414_007, ANDA062414_008, ANDA062414_009, ANDA062414_010
17ANDA062420GENTAMICIN SULFATEHOSPIRA INC1983-08-15ANDA062420_001, ANDA062420_002
18ANDA062493GENTAFAIRTruePHARMAFAIR INC1985-08-28ANDA062493_001
19ANDA062507GENTAMICIN SULFATETrueSOLOPAK LABORATORIES INC1985-06-06ANDA062507_001, ANDA062507_002
20ANDA062588GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERTrueHOSPIRA INC1986-01-06ANDA062588_001, ANDA062588_002, ANDA062588_003, ANDA062588_004, ANDA062588_005, ANDA062588_006, ANDA062588_007, ANDA062588_008, ANDA062588_009, ANDA062588_010
21ANDA062612GENTAMICIN SULFATEHOSPIRA INC1986-02-20ANDA062612_004
22ANDA062814GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERB BRAUN MEDICAL INC1987-08-28ANDA062814_001, ANDA062814_002, ANDA062814_003, ANDA062814_004, ANDA062814_005, ANDA062814_006, ANDA062814_007, ANDA062814_008, ANDA062814_009, ANDA062814_010, ANDA062814_011, ANDA062814_012, ANDA062814_013, ANDA062814_014
23ANDA063106GENTAMICIN SULFATETrueTEVA PARENTERAL MEDICINES INC1991-11-21ANDA063106_002
24ANDA063149GENTAMICIN SULFATETrueTEVA PARENTERAL MEDICINES INC1991-11-21ANDA063149_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA061716_001discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseGARAMYCIN
2ANDA061716_002discontinuedGENTAMICIN SULFATE (EQ 1MG BASE/ML)INJECTIONFalseGARAMYCIN
3ANDA061739_001discontinuedGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseGARAMYCIN
4ANDA062248_001discontinuedGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseU-GENCIN
5ANDA062248_002discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseU-GENCIN
6ANDA062251_001discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseGENTAMICIN SULFATE
7ANDA062251_002discontinuedGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseGENTAMICIN SULFATE
8ANDA062264_001discontinuedGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseGENTAMICIN SULFATE
9ANDA062264_002discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseGENTAMICIN SULFATE
10ANDA062288_001discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseBRISTAGEN
11ANDA062289_001discontinuedGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseAPOGEN
12ANDA062289_002discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseAPOGEN
13ANDA062318_001discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseGENTAMICIN SULFATE
14ANDA062318_002discontinuedGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseGENTAMICIN SULFATE
15ANDA062325_001discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseGENTAMICIN
16ANDA062325_003discontinuedGENTAMICIN SULFATE (EQ 1MG BASE/ML)INJECTIONFalse1982-06-23GENTAMICIN
17ANDA062325_004discontinuedGENTAMICIN SULFATE (EQ 100MG BASE/100ML)INJECTIONFalse1982-06-23GENTAMICIN
18ANDA062340_001discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1983-03-28GENTAMICIN SULFATE
19ANDA062354_001discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1982-04-05GENTAMICIN SULFATE
20ANDA062356_001discontinuedGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1982-03-04GENTAMICIN SULFATE
21ANDA062356_002discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1982-03-04GENTAMICIN SULFATE
22ANDA062366_001RXGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONTrueAP1983-08-04GENTAMICIN SULFATE
23ANDA062366_002RXGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseAP1986-02-06GENTAMICIN SULFATE
24ANDA062373_001RXGENTAMICIN SULFATE (EQ 0.8MG BASE/ML)INJECTIONFalseAP1982-09-07ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
25ANDA062373_002RXGENTAMICIN SULFATE (EQ 80MG BASE/100ML)INJECTIONFalseAP1982-09-07ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
26ANDA062373_003RXGENTAMICIN SULFATE (EQ 40MG BASE/100ML)INJECTIONFalseAP1982-09-07ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
27ANDA062373_004RXGENTAMICIN SULFATE (EQ 60MG BASE/100ML)INJECTIONFalseAP1982-09-07ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
28ANDA062373_005RXGENTAMICIN SULFATE (EQ 100MG BASE/100ML)INJECTIONFalseAP1982-09-07ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
29ANDA062373_006RXGENTAMICIN SULFATE (EQ 120MG BASE/100ML)INJECTIONFalseAP1982-09-07ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
30ANDA062373_007RXGENTAMICIN SULFATE (EQ 1.2MG BASE/ML)INJECTIONFalseAP1982-09-07ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
31ANDA062373_008RXGENTAMICIN SULFATE (EQ 1.6MG BASE/ML)INJECTIONFalseAP1982-09-07ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
32ANDA062373_009RXGENTAMICIN SULFATE (EQ 2MG BASE/ML)INJECTIONFalseAP1982-09-07ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
33ANDA062373_010RXGENTAMICIN SULFATE (EQ 2.4MG BASE/ML)INJECTIONFalseAP1982-09-07ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
34ANDA062413_001discontinuedGENTAMICIN SULFATE (EQ 1.2MG BASE/ML)INJECTIONFalse1983-08-11GENTAMICIN SULFATE
35ANDA062413_002discontinuedGENTAMICIN SULFATE (EQ 1.4MG BASE/ML)INJECTIONFalse1983-08-11GENTAMICIN SULFATE
36ANDA062413_003discontinuedGENTAMICIN SULFATE (EQ 1.6MG BASE/ML)INJECTIONFalse1983-08-11GENTAMICIN SULFATE
37ANDA062413_004discontinuedGENTAMICIN SULFATE (EQ 1.8MG BASE/ML)INJECTIONFalse1983-08-11GENTAMICIN SULFATE
38ANDA062413_005discontinuedGENTAMICIN SULFATE (EQ 2MG BASE/ML)INJECTIONFalse1983-08-11GENTAMICIN SULFATE
39ANDA062413_006discontinuedGENTAMICIN SULFATE (EQ 60MG BASE/100ML)INJECTIONFalse1983-08-11GENTAMICIN SULFATE
40ANDA062413_007discontinuedGENTAMICIN SULFATE (EQ 70MG BASE/100ML)INJECTIONFalse1983-08-11GENTAMICIN SULFATE
41ANDA062413_008discontinuedGENTAMICIN SULFATE (EQ 80MG BASE/100ML)INJECTIONFalse1983-08-11GENTAMICIN SULFATE
42ANDA062413_009discontinuedGENTAMICIN SULFATE (EQ 90MG BASE/100ML)INJECTIONFalse1983-08-11GENTAMICIN SULFATE
43ANDA062413_010discontinuedGENTAMICIN SULFATE (EQ 100MG BASE/100ML)INJECTIONFalse1983-08-11GENTAMICIN SULFATE
44ANDA062414_001RXGENTAMICIN SULFATE (EQ 1.2MG BASE/ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
45ANDA062414_002RXGENTAMICIN SULFATE (EQ 1.4MG BASE/ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
46ANDA062414_003RXGENTAMICIN SULFATE (EQ 1.6MG BASE/ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
47ANDA062414_004RXGENTAMICIN SULFATE (EQ 1.8MG BASE/ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
48ANDA062414_005RXGENTAMICIN SULFATE (EQ 2MG BASE/ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
49ANDA062414_006RXGENTAMICIN SULFATE (EQ 60MG BASE/100ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
50ANDA062414_007RXGENTAMICIN SULFATE (EQ 70MG BASE/100ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
51ANDA062414_008RXGENTAMICIN SULFATE (EQ 80MG BASE/100ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
52ANDA062414_009RXGENTAMICIN SULFATE (EQ 90MG BASE/100ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
53ANDA062414_010RXGENTAMICIN SULFATE (EQ 100MG BASE/100ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
54ANDA062420_001RXGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE
55ANDA062420_002RXGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseAP1983-08-15GENTAMICIN SULFATE
56ANDA062493_001discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1985-08-28GENTAFAIR
57ANDA062507_001discontinuedGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1985-06-06GENTAMICIN SULFATE
58ANDA062507_002discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1985-06-06GENTAMICIN SULFATE
59ANDA062588_001discontinuedGENTAMICIN SULFATE (EQ 1.2MG BASE/ML)INJECTIONFalse1986-01-06GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
60ANDA062588_002discontinuedGENTAMICIN SULFATE (EQ 1.4MG BASE/ML)INJECTIONFalse1986-01-06GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
61ANDA062588_003discontinuedGENTAMICIN SULFATE (EQ 1.6MG BASE/ML)INJECTIONFalse1986-01-06GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
62ANDA062588_004discontinuedGENTAMICIN SULFATE (EQ 1.8MG BASE/ML)INJECTIONFalse1986-01-06GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
63ANDA062588_005discontinuedGENTAMICIN SULFATE (EQ 2MG BASE/ML)INJECTIONFalse1986-01-06GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
64ANDA062588_006discontinuedGENTAMICIN SULFATE (EQ 60MG BASE/100ML)INJECTIONFalse1986-01-06GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
65ANDA062588_007discontinuedGENTAMICIN SULFATE (EQ 70MG BASE/100ML)INJECTIONFalse1986-01-06GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
66ANDA062588_008discontinuedGENTAMICIN SULFATE (EQ 80MG BASE/100ML)INJECTIONFalse1986-01-06GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
67ANDA062588_009discontinuedGENTAMICIN SULFATE (EQ 90MG BASE/100ML)INJECTIONFalse1986-01-06GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
68ANDA062588_010discontinuedGENTAMICIN SULFATE (EQ 100MG BASE/100ML)INJECTIONFalse1986-01-06GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
69ANDA062612_004RXGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseAP1986-02-20GENTAMICIN SULFATE
70ANDA062814_001RXGENTAMICIN SULFATE (EQ 0.8MG BASE/ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
71ANDA062814_002RXGENTAMICIN SULFATE (EQ 1.2MG BASE/ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
72ANDA062814_003RXGENTAMICIN SULFATE (EQ 1.4MG BASE/ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
73ANDA062814_004RXGENTAMICIN SULFATE (EQ 1.6MG BASE/ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
74ANDA062814_005RXGENTAMICIN SULFATE (EQ 1.8MG BASE/ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
75ANDA062814_006RXGENTAMICIN SULFATE (EQ 2MG BASE/ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
76ANDA062814_007RXGENTAMICIN SULFATE (EQ 2.4MG BASE/ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
77ANDA062814_008RXGENTAMICIN SULFATE (EQ 40MG BASE/100ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
78ANDA062814_009RXGENTAMICIN SULFATE (EQ 60MG BASE/100ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
79ANDA062814_010RXGENTAMICIN SULFATE (EQ 70MG BASE/100ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
80ANDA062814_011RXGENTAMICIN SULFATE (EQ 80MG BASE/100ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
81ANDA062814_012RXGENTAMICIN SULFATE (EQ 90MG BASE/100ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
82ANDA062814_013RXGENTAMICIN SULFATE (EQ 100MG BASE/100ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
83ANDA062814_014RXGENTAMICIN SULFATE (EQ 120MG BASE/100ML)INJECTIONTrueAP1987-08-28GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
84ANDA063106_002discontinuedGENTAMICIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1991-11-21GENTAMICIN SULFATE
85ANDA063149_001discontinuedGENTAMICIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1991-11-21GENTAMICIN SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10cce2238-28d3-4280-b520-ffc3067a2ffa (view SPL)Gentamicin Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-08-151633230010
21bf429e3-6e0c-4244-ba1a-af1a3a153c24 (view SPL)Gentamicin Sulfate 40 mg/mL Injection, USP 2 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-031525840207
31dd0d718-2ca7-4371-b726-5d67a2673fdf (view SPL)Gentamicin Injection USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-03-042551549365
42fcd1c1f-bd01-42c7-2c89-5eee2fe7055b (view SPL)prescriptionHuman PrescriptionHospira, Inc.2011-07-0610004097879, 004097881, 004097883, 004097884, 004097886, 004097889
5449c9a41-d61e-49fd-b5e3-d76f74b92acf (view SPL)Gentamicin Sulfate in 0.9% Sodium Chloride Injection in Plastic Container VIAFLEX Plus Container For Intravenous AdministrationFurther Dilution Not RequiredprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2011-06-097003380501, 003380503, 003380505, 003380507, 003380509, 003380511
64f35bd00-b600-4972-6cba-ea5702f7d9bc (view SPL)GENTAMICIN SULFATE INJECTION, USPprescriptionHuman PrescriptionHospira, Inc.2012-01-273004093400, 004093401, 004093402
75113bfad-42ca-4bb8-9343-0b08c6cd03f0 (view SPL)GENTAMICINSULFATEInjection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-224551542392
863413469-c676-48a3-a945-7d2489b535ef (view SPL)Gentamicin Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-09-261633230173
98104ee83-6e67-4e61-8cb2-854fc72cd87d (view SPL)Gentamicin 40 mg/mL Injection, USP 20 mL Multi Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2015-08-195525840010
1084f5c763-1cd3-4d85-9afb-934db8666fbf (view SPL)Gentamicin Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-09-261633230010
118bdeef7f-ad8e-46e0-a872-e945eae51d68 (view SPL)Gentamicin Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-08-151633230173
12977180b3-a222-4282-d485-4a3217674305 (view SPL)GENTAMICINSULFATEInjection, USPprescriptionHuman PrescriptionHospira, Inc.2014-06-1713004091207
13a73a5453-c091-43fd-aae2-d992152363b1 (view SPL)Gentamicin Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-09-242633230010
14bb2e10d2-1500-4dde-8281-8ab44abf28f0 (view SPL)GENTAMICIN SULFATE Injection USPprescriptionHuman PrescriptionHospira, Inc.analysis, api manufacture, manufacture2014-07-031004091207
15be5b414e-d598-4721-80ee-5836156ad210 (view SPL)Gentamicin Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-07-242633230173
16ca625340-377b-4256-92e2-d62471a8d852 (view SPL)Gentamicin Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-09-302633230513
17df42df85-1ce1-41e8-876f-40d4a8c8b67d (view SPL)Gentamicin Injection USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-04-171551549552
18faa12ba9-072d-465e-9753-4ab4f1e3b6c6 (view SPL)Gentamicin Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-05-011551549376

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