Amikacin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceuticals Corp. (2015-11-18)
Oldest Current Product
2013-12-24
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\AMIKACIN
FDAOB
INJECTION\INJECTION\AMIKACIN SULFATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\AMIKACIN SULFATE
INTRAMUSCULAR\INJECTION\AMIKACIN SULFATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\AMIKACIN
INTRAMUSCULAR\INJECTION\AMIKACIN

product(s) by strength(s)

amikacin sulfate 250 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416166ANDAWest-Ward Pharmaceuticals Corp.2015-08-01AMIKACIN SULFATEINTRAMUSCULARINJECTIONANDA0633150b56f6df-a05d-4520-8bf0-d7cefe20f6ad
2006416167ANDAWest-Ward Pharmaceuticals Corp.2015-08-01AMIKACIN SULFATEINTRAMUSCULARINJECTIONANDA0633150b56f6df-a05d-4520-8bf0-d7cefe20f6ad
3007039032ANDATeva Parenteral Medicines, Inc1993-10-01, 2014-11-26AMIKACIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA0640456ec3129b-c53b-4bdb-913d-a2d0060fa140, a47f8cf6-dbdc-46f7-b0a0-e56adcb8b087
4007039040ANDATeva Parenteral Medicines, Inc1993-10-01, 2014-11-26AMIKACIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA0640456ec3129b-c53b-4bdb-913d-a2d0060fa140, a47f8cf6-dbdc-46f7-b0a0-e56adcb8b087
5231550290ANDAHeritage Pharmaceuticals Inc.2013-12-24AMIKACIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA204040a43188fa-f228-4acd-8a5d-9a3462034f4b

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062311AMIKINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA062311_001, ANDA062311_002
2ANDA062562AMIKINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1984-09-20ANDA062562_001, ANDA062562_002
3ANDA063167AMIKACIN SULFATETrueIGI LABORATORIES INC1995-12-14ANDA063167_001
4ANDA063169AMIKACIN SULFATETrueIGI LABORATORIES INC1995-12-14ANDA063169_001
5ANDA063263AMIKACIN SULFATETrueHOSPIRA INC1994-11-30ANDA063263_001
6ANDA063264AMIKACIN SULFATETrueHOSPIRA INC1994-11-30ANDA063264_001
7ANDA063265AMIKACIN SULFATETrueABBOTT LABORATORIES1994-11-30ANDA063265_001
8ANDA063266AMIKACIN SULFATETrueABBOTT LABORATORIES HOSP PRODUCTS DIV1994-10-31ANDA063266_001
9ANDA063274AMIKACIN SULFATETrueHIKMA MAPLE LTD1992-05-18ANDA063274_001
10ANDA063275AMIKACIN SULFATETrueHIKMA MAPLE LTD1992-05-18ANDA063275_001
11ANDA063283AMIKACIN SULFATETrueHOSPIRA INC1994-10-31ANDA063283_001
12ANDA063313AMIKACIN SULFATEEUROHEALTH INTERNATIONAL SARL1994-04-11ANDA063313_001
13ANDA063315AMIKACIN SULFATEEUROHEALTH INTERNATIONAL SARL1994-04-11ANDA063315_001
14ANDA063350AMIKACIN SULFATETrueHOSPIRA INC1993-07-30ANDA063350_001, ANDA063350_002
15ANDA064045AMIKACIN SULFATETEVA PHARMACEUTICALS USA1993-09-28ANDA064045_001, ANDA064045_002
16ANDA064098AMIKACIN SULFATETrueHOSPIRA INC1995-06-26ANDA064098_001
17ANDA064099AMIKACIN SULFATETrueHOSPIRA INC1995-06-20ANDA064099_001
18ANDA064146AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERTrueHOSPIRA WORLDWIDE, INC1997-04-02ANDA064146_001
19ANDA204040AMIKACIN SULFATEEMCURE PHARMACEUTICALS LTD2013-12-12ANDA204040_001
20NDA050495AMIKINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBNDA050495_001, NDA050495_002
21NDA050618AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1987-11-30NDA050618_001, NDA050618_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA062311_001discontinuedAMIKACIN SULFATE (EQ 50MG BASE/ML)INJECTIONFalseAMIKIN
2ANDA062311_002discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalseAMIKIN
3ANDA062562_001discontinuedAMIKACIN SULFATE (EQ 50MG BASE/ML)INJECTIONFalse1984-09-20AMIKIN
4ANDA062562_002discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalse1984-09-20AMIKIN
5ANDA063167_001discontinuedAMIKACIN SULFATE (EQ 50MG BASE/ML)INJECTIONFalse1995-12-14AMIKACIN SULFATE
6ANDA063169_001discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalse1995-12-14AMIKACIN SULFATE
7ANDA063263_001discontinuedAMIKACIN SULFATE (EQ 50MG BASE/ML)INJECTIONFalse1994-11-30AMIKACIN SULFATE
8ANDA063264_001discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalse1994-11-30AMIKACIN SULFATE
9ANDA063265_001discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalse1994-11-30AMIKACIN SULFATE
10ANDA063266_001discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalse1994-10-31AMIKACIN SULFATE
11ANDA063274_001discontinuedAMIKACIN SULFATE (EQ 50MG BASE/ML)INJECTIONFalse1992-05-18AMIKACIN SULFATE
12ANDA063275_001discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalse1992-05-18AMIKACIN SULFATE
13ANDA063283_001discontinuedAMIKACIN SULFATE (EQ 62.5MG BASE/ML)INJECTIONFalse1994-10-31AMIKACIN SULFATE
14ANDA063313_001RXAMIKACIN SULFATE (EQ 50MG BASE/ML)INJECTIONTrueAP1994-04-11AMIKACIN SULFATE
15ANDA063315_001RXAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONTrueAP1994-04-11AMIKACIN SULFATE
16ANDA063350_001discontinuedAMIKACIN SULFATE (EQ 50MG BASE/ML)INJECTIONFalse1993-07-30AMIKACIN SULFATE
17ANDA063350_002discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalse1993-07-30AMIKACIN SULFATE
18ANDA064045_001discontinuedAMIKACIN SULFATE (EQ 50MG BASE/ML)INJECTIONFalse1993-09-28AMIKACIN SULFATE
19ANDA064045_002RXAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalseAP1993-09-28AMIKACIN SULFATE
20ANDA064098_001discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalse1995-06-26AMIKACIN SULFATE
21ANDA064099_001discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalse1995-06-20AMIKACIN SULFATE
22ANDA064146_001discontinuedAMIKACIN SULFATE (EQ 500MG BASE/100ML)INJECTIONFalse1997-04-02AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
23ANDA204040_001RXAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalseAP2013-12-12AMIKACIN SULFATE
24NDA050495_001discontinuedAMIKACIN SULFATE (EQ 50MG BASE/ML)INJECTIONFalseAMIKIN
25NDA050495_002discontinuedAMIKACIN SULFATE (EQ 250MG BASE/ML)INJECTIONFalseAMIKIN
26NDA050618_001discontinuedAMIKACIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1987-11-30AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
27NDA050618_002discontinuedAMIKACIN SULFATE (EQ 5MG BASE/ML)INJECTIONFalse1987-11-30AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b56f6df-a05d-4520-8bf0-d7cefe20f6ad (view SPL)AMIKACIN SULFATE INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE, PACK2015-11-183006416166, 006416167
26ec3129b-c53b-4bdb-913d-a2d0060fa140 (view SPL)Amikacin Sulfate Injection USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-10-298007039032, 007039040
3a43188fa-f228-4acd-8a5d-9a3462034f4b (view SPL)Amikacin Sulfate Injection, USP Rx ONLYprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-10-179231550290
4a47f8cf6-dbdc-46f7-b0a0-e56adcb8b087 (view SPL)Amikacin Sulfate Injection USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-09-153007039032, 007039040

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