Tobramycin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2011-08-24)
Oldest Current Product
1990-07-31
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\TOBRAMYCIN
FDAOB
INJECTION\INJECTION\TOBRAMYCIN SULFATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\TOBRAMYCIN SULFATE
INTRAMUSCULAR\INJECTION\TOBRAMYCIN SULFATE
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\TOBRAMYCIN SULFATE
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TOBRAMYCIN SULFATE
INTRAVENOUS\INJECTION, SOLUTION\TOBRAMYCIN SULFATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\TOBRAMYCIN
INTRAMUSCULAR\INJECTION\TOBRAMYCIN
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\TOBRAMYCIN
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TOBRAMYCIN
INTRAVENOUS\INJECTION, SOLUTION\TOBRAMYCIN

product(s) by strength(s)

tobramycin 0.8 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093470ANDAHospira, Inc.1990-07-31TOBRAMYCIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA063081ee907146-e4a8-4578-a9b0-c8e9790e3d55

tobramycin 1.2 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004093469ANDAHospira, Inc.1990-07-312010-11-01TOBRAMYCIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA063081ee907146-e4a8-4578-a9b0-c8e9790e3d55

tobramycin 10 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093577ANDAHospira, Inc.1991-04-30TOBRAMYCIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA063112c5a005b0-7b6f-4e30-df92-9a20b1ca66a1
2633230305ANDAApp Pharmaceuticals, Llc2004-11-30TOBRAMYCIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA065122d6dd9460-b030-479a-b3e3-03606e6fcad1

tobramycin 40 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230303NDAApp Pharmaceuticals, Llc2005-11-23TOBRAMYCIN SULFATEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA050789d62ff359-912b-4be1-9fc2-2dde8777eefb

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690088ANDAPfizer Labs2011-05-10TOBRAMYCIN SULFATEINTRAMUSCULARINJECTIONANDA0654073d9670bd-c8ae-41ce-9479-bdf6ce16ef52
2000690091ANDAPfizer Labs2011-05-10TOBRAMYCIN SULFATEINTRAMUSCULARINJECTIONANDA0654073d9670bd-c8ae-41ce-9479-bdf6ce16ef52
3000690301ANDAPfizer Labs2011-05-10TOBRAMYCIN SULFATEINTRAMUSCULARINJECTIONANDA06540786681c94-58dd-46a2-bb6c-239223a585bf
4000690302ANDAPfizer Labs2011-05-10TOBRAMYCIN SULFATEINTRAMUSCULARINJECTIONANDA06540786681c94-58dd-46a2-bb6c-239223a585bf
5004093578ANDAHospira, Inc.1991-04-30TOBRAMYCIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA063111c5a005b0-7b6f-4e30-df92-9a20b1ca66a1
6174780114ANDAAkorn2014-09-16TOBRAMYCIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA2051796168205f-e917-4826-9519-f444aa51a5b2
7398220409ANDAX-Gen Pharmaceuticals, Inc.2001-08-17TOBRAMYCIN SULFATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0650133cb82c1f-b0b9-4e90-ae3d-15f866a4e0e5
8398220412ANDAX-Gen Pharmaceuticals, Inc.2001-08-17TOBRAMYCIN SULFATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065013a384641c-04e3-4ab5-b152-7408cd07b64d
9633230306ANDAApp Pharmaceuticals, Llc2005-11-23TOBRAMYCIN SULFATEINTRAMUSCULARINJECTION, SOLUTIONANDA0651226aab2c4c-148a-4fce-af07-41cd086d9e9c, d6dd9460-b030-479a-b3e3-03606e6fcad1
10633230307ANDAApp Pharmaceuticals, Llc2004-11-30TOBRAMYCIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA0651208cfeb84f-193a-458a-bdec-205d9274e1a4
11674570432ANDAMylan Institutional Llc2008-03-12TOBRAMYCIN SULFATEINTRAMUSCULARINJECTIONANDA06540785117124-29bb-4a2b-9a82-f2fc2802aed1
12674570473ANDAMylan Institutional Llc2011-05-10TOBRAMYCIN SULFATEINTRAMUSCULARINJECTIONANDA065407ac8134d9-a726-4508-b8b9-a536ef17243d

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093590ANDAHospira, Inc.1992-05-18TOBRAMYCIN SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA0631164e115874-3637-4aed-b6af-77d53a850208

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062008NEBCINTrueELI LILLY AND COANDA062008_001, ANDA062008_004
2ANDA062707NEBCINTrueELI LILLY AND CO1987-04-29ANDA062707_001
3ANDA062945TOBRAMYCIN SULFATETrueWATSON LABORATORIES INC1989-08-09ANDA062945_001, ANDA062945_002
4ANDA063080TOBRAMYCIN SULFATETrueHOSPIRA WORLDWIDE, INC1991-04-30ANDA063080_001
5ANDA063081TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHOSPIRA INC1990-07-31ANDA063081_001, ANDA063081_003, ANDA063081_006
6ANDA063100TOBRAMYCIN SULFATETEVA PHARMACEUTICALS USA1992-01-30ANDA063100_001
7ANDA063111TOBRAMYCIN SULFATEHOSPIRA INC1991-04-30ANDA063111_001
8ANDA063112TOBRAMYCIN SULFATEHOSPIRA WORLDWIDE, INC1991-04-30ANDA063112_001
9ANDA063113TOBRAMYCIN SULFATETrueHIKMA MAPLE LTD1991-04-26ANDA063113_001
10ANDA063116TOBRAMYCIN SULFATE (PHARMACY BULK)TrueHOSPIRA INC1992-05-18ANDA063116_001
11ANDA063117TOBRAMYCIN SULFATEHIKMA MAPLE LTD1991-04-26ANDA063117_001
12ANDA063118TOBRAMYCIN SULFATETrueHIKMA MAPLE LTD1991-07-29ANDA063118_001
13ANDA063119TOBRAMYCIN SULFATETrueIGI LABORATORIES INC1994-10-31ANDA063119_001
14ANDA063120TOBRAMYCIN SULFATETrueIGI LABORATORIES INC1994-10-31ANDA063120_001
15ANDA063121TOBRAMYCIN SULFATETrueIGI LABORATORIES INC1994-10-31ANDA063121_001
16ANDA063122TOBRAMYCIN SULFATETrueIGI LABORATORIES INC1994-10-31ANDA063122_001
17ANDA063127TOBRAMYCIN SULFATETrueHIKMA MAPLE LTD1991-11-27ANDA063127_001
18ANDA063128TOBRAMYCIN SULFATETrueHIKMA MAPLE LTD1991-11-27ANDA063128_001
19ANDA063161TOBRAMYCIN SULFATETrueHOSPIRA INC1991-05-29ANDA063161_001
20ANDA064021TOBRAMYCIN SULFATETrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1994-05-31ANDA064021_001, ANDA064021_002
21ANDA064026TOBRAMYCIN SULFATETrueAPOTHECON INC DIV BRISTOL MYERS SQUIBB1994-05-31ANDA064026_001
22ANDA065013TOBRAMYCIN SULFATEX GEN PHARMACEUTICALS INC2001-08-17ANDA065013_001
23ANDA065120TOBRAMYCIN SULFATE (PHARMACY BULK)FRESENIUS KABI USA LLC2002-11-29ANDA065120_001
24ANDA065122TOBRAMYCIN SULFATEFRESENIUS KABI USA LLC2002-11-29ANDA065122_001, ANDA065122_002
25ANDA065407TOBRAMYCIN SULFATEMYLAN LABORATORIES LTD2008-03-11ANDA065407_001
26ANDA205179TOBRAMYCIN SULFATEAKORN INC2014-09-16ANDA205179_001
27ANDA205685TOBRAMYCIN SULFATEXELLIA PHARMACEUTICALS APS2014-09-16ANDA205685_001
28NDA050477NEBCINTrueELI LILLY AND CONDA050477_005
29NDA050519NEBCINTrueELI LILLY AND CONDA050519_001
30NDA050789TOBRAMYCIN SULFATEFRESENIUS KABI USA LLC2004-07-13NDA050789_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA062008_001discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseNEBCIN
2ANDA062008_004discontinuedTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseNEBCIN
3ANDA062707_001discontinuedTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1987-04-29NEBCIN
4ANDA062945_001discontinuedTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1989-08-09TOBRAMYCIN SULFATE
5ANDA062945_002discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1989-08-09TOBRAMYCIN SULFATE
6ANDA063080_001discontinuedTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1991-04-30TOBRAMYCIN SULFATE
7ANDA063081_001RXTOBRAMYCIN SULFATE (EQ 80MG BASE/100ML)INJECTIONTrue1990-07-31TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
8ANDA063081_003RXTOBRAMYCIN SULFATE (EQ 1.2MG BASE/ML)INJECTIONTrue1990-07-31TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
9ANDA063081_006RXTOBRAMYCIN SULFATE (EQ 1.6MG BASE/ML)INJECTIONTrue1993-06-02TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
10ANDA063100_001RXTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseAP1992-01-30TOBRAMYCIN SULFATE
11ANDA063111_001RXTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseAP1991-04-30TOBRAMYCIN SULFATE
12ANDA063112_001RXTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONTrueAP1991-04-30TOBRAMYCIN SULFATE
13ANDA063113_001discontinuedTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1991-04-26TOBRAMYCIN SULFATE
14ANDA063116_001discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1992-05-18TOBRAMYCIN SULFATE (PHARMACY BULK)
15ANDA063117_001RXTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseAP1991-04-26TOBRAMYCIN SULFATE
16ANDA063118_001discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1991-07-29TOBRAMYCIN SULFATE
17ANDA063119_001discontinuedTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1994-10-31TOBRAMYCIN SULFATE
18ANDA063120_001discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1994-10-31TOBRAMYCIN SULFATE
19ANDA063121_001discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1994-10-31TOBRAMYCIN SULFATE
20ANDA063122_001discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1994-10-31TOBRAMYCIN SULFATE
21ANDA063127_001discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1991-11-27TOBRAMYCIN SULFATE
22ANDA063128_001discontinuedTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1991-11-27TOBRAMYCIN SULFATE
23ANDA063161_001discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1991-05-29TOBRAMYCIN SULFATE
24ANDA064021_001discontinuedTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalse1994-05-31TOBRAMYCIN SULFATE
25ANDA064021_002discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1994-05-31TOBRAMYCIN SULFATE
26ANDA064026_001discontinuedTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalse1994-05-31TOBRAMYCIN SULFATE
27ANDA065013_001RXTOBRAMYCIN SULFATE (EQ 1.2GM BASE/VIAL)INJECTIONTrueAP2001-08-17TOBRAMYCIN SULFATE
28ANDA065120_001RXTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONTrue2002-11-29TOBRAMYCIN SULFATE (PHARMACY BULK)
29ANDA065122_001RXTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseAP2002-11-29TOBRAMYCIN SULFATE
30ANDA065122_002RXTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONTrueAP2002-11-29TOBRAMYCIN SULFATE
31ANDA065407_001RXTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseAP2008-03-11TOBRAMYCIN SULFATE
32ANDA205179_001RXTOBRAMYCIN SULFATE (EQ 40MG BASE/ML)INJECTIONFalseAP2014-09-16TOBRAMYCIN SULFATE
33ANDA205685_001RXTOBRAMYCIN SULFATE (EQ 1.2GM BASE/VIAL)INJECTIONFalseAP2014-09-16TOBRAMYCIN SULFATE
34NDA050477_005discontinuedTOBRAMYCIN SULFATE (EQ 10MG BASE/ML)INJECTIONFalseNEBCIN
35NDA050519_001discontinuedTOBRAMYCIN SULFATE (EQ 1.2GM BASE/VIAL)INJECTIONFalseNEBCIN
36NDA050789_001RXTOBRAMYCIN SULFATE (EQ 1.2GM BASE/VIAL)INJECTIONFalseAP2004-07-13TOBRAMYCIN SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13cb82c1f-b0b9-4e90-ae3d-15f866a4e0e5 (view SPL)Tobramycin for Injection USP, 1.2 gmprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2015-05-077398220409
23d9670bd-c8ae-41ce-9479-bdf6ce16ef52 (view SPL)tobramycin injection USPprescriptionHuman PrescriptionPfizer LabsAPI MANUFACTURE, MANUFACTURE2013-04-045000690088, 000690091
34e115874-3637-4aed-b6af-77d53a850208 (view SPL)TobramycinprescriptionHuman PrescriptionHospira, Inc.2013-11-1913004093590
46168205f-e917-4826-9519-f444aa51a5b2 (view SPL)TOBRAMYCIN INJECTION, USPprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-07-292174780114
56aab2c4c-148a-4fce-af07-41cd086d9e9c (view SPL)Tobramycin Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-05-011633230306
685117124-29bb-4a2b-9a82-f2fc2802aed1 (view SPL)Tobramycin Injection, USPRx onlyprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-05-062674570432
786681c94-58dd-46a2-bb6c-239223a585bf (view SPL)Tobramycin Injection USPprescriptionHuman PrescriptionPfizer LabsAPI MANUFACTURE, MANUFACTURE2013-04-042000690301, 000690302
88cfeb84f-193a-458a-bdec-205d9274e1a4 (view SPL)Tobramycin Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-07-032633230307
9a384641c-04e3-4ab5-b152-7408cd07b64d (view SPL)Tobramycin for Injection USP, 1.2 gmprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2015-04-2316398220412
10ac8134d9-a726-4508-b8b9-a536ef17243d (view SPL)Tobramycin Injection, USP Rx onlyprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-04-303674570473
11c5a005b0-7b6f-4e30-df92-9a20b1ca66a1 (view SPL)TobramycinprescriptionHuman PrescriptionHospira, Inc.2013-11-1112004093577, 004093578
12d62ff359-912b-4be1-9fc2-2dde8777eefb (view SPL)Tobramycin for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-08-241633230303
13d6dd9460-b030-479a-b3e3-03606e6fcad1 (view SPL)Tobramycin Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-02-172633230305, 633230306
14ee907146-e4a8-4578-a9b0-c8e9790e3d55 (view SPL)TobramycinprescriptionHuman PrescriptionHospira, Inc.2013-11-1112004093469, 004093470

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