gemcitabine Injection

Brand(s)
Gemzar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eli Lilly And Company (2014-06-10)
Oldest Current Product
1996-05-22
License(s)
NDA, ANDA
RxNORM
INJECTION\GEMCITABINE
FDAOB
INJECTION\INJECTION\GEMCITABINE HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\GEMCITABINE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\GEMCITABINE HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\GEMCITABINE
INTRAVENOUS\INJECTION, SOLUTION\GEMCITABINE

product(s) by strength(s)

gemcitabine 1000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000027502GemzarNDAEli Lilly And Company1996-05-22GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0205099dc35c59-f4f3-43b4-8251-0cf5c06cdc80

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090186ANDAHospira, Inc.2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA078339d16907e7-a8c8-4039-ace4-cf4e24ba68c0
2005913563ANDAWatson Laboratories, Inc.2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0787596004fba9-49c0-4781-8134-44bf7cf196fd
3167290117ANDAAccord Healthcare Inc.2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091594c90cdf38-2b2a-4d8c-a7b5-373787173193
4231550214ANDAHeritage Pharmaceuticals Inc.2012-10-22GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA20206349f9e774-52f9-40af-aecf-217c11e243ce
5250210209ANDASagent Pharmaceuticals2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA079160ffc0a4be-6091-4157-837e-3637c1e121a6
6250210235ANDASagent Pharmaceuticals2014-12-29GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA20248544bcc16c-341d-49e8-a1c6-95d084667aca
7422360002ANDAHameln Rds Gmbh2012-09-20GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA090663ba288004-daec-4b80-9041-cc72c63ba2c4
8459630619ANDAActavis Inc.2015-01-05GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0791601eeacf1b-0d89-4cfa-956d-dcb5880b431b
9473350154ANDASun Pharma Global Fze2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0784336087be15-56c1-4794-b159-ad9082b631b9
10551110687ANDADr. Reddy'S Laboratories Ltd2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091365eafcebc8-ddef-bb6b-fd0a-9d8b9962cdc4
11633230125ANDAApp Pharmaceuticals, Llc2011-07-26GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA090799c550dd16-a5e8-44be-87f2-210c15bbb513

gemcitabine 200 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000027501GemzarNDAEli Lilly And Company1996-05-22GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0205099dc35c59-f4f3-43b4-8251-0cf5c06cdc80

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000693857ANDAPfizer Labs2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA200145632a8105-9cb2-44ba-8c10-2a1efd6ac960
2004090185ANDAHospira, Inc.2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA078339d16907e7-a8c8-4039-ace4-cf4e24ba68c0
3005913562ANDAWatson Laboratories, Inc.2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0787596004fba9-49c0-4781-8134-44bf7cf196fd
4167290092ANDAAccord Healthcare Inc.2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091594c90cdf38-2b2a-4d8c-a7b5-373787173193
5231550213ANDAHeritage Pharmaceuticals Inc.2012-10-22GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA20206349f9e774-52f9-40af-aecf-217c11e243ce
6231550483ANDAHeritage Pharmaceuticals Inc.2012-10-22GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA20206381399444-3a4f-4a22-ab1d-b99896f3a211
7231550528ANDAHeritage Pharmaceuticals Inc.2012-10-22GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA202063cebd1bac-f2a2-46f2-ac5c-021a46bfcc9b
8250210208ANDASagent Pharmaceuticals2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA079160ffc0a4be-6091-4157-837e-3637c1e121a6
9250210234ANDASagent Pharmaceuticals2014-12-29GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA20248544bcc16c-341d-49e8-a1c6-95d084667aca
10422360001ANDAHameln Rds Gmbh2012-09-20GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA090663ba288004-daec-4b80-9041-cc72c63ba2c4
11459630612ANDAActavis Inc.2015-01-05GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0791601eeacf1b-0d89-4cfa-956d-dcb5880b431b
12473350153ANDASun Pharma Global Fze2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0784336087be15-56c1-4794-b159-ad9082b631b9
13551110686ANDADr. Reddy'S Laboratories Ltd2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091365eafcebc8-ddef-bb6b-fd0a-9d8b9962cdc4
14633230102ANDAApp Pharmaceuticals, Llc2011-07-26GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA090799c550dd16-a5e8-44be-87f2-210c15bbb513
15674570464ANDAMylan Institutional Llc2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA200145fdf52dca-732c-4a1a-9475-e9e1e3af4ce8

gemcitabine 2000 mg injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090187ANDAHospira, Inc.2010-11-15GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA079183a625c92b-c569-4b98-8d2e-2b3f5e12b34f
2167290118ANDAAccord Healthcare Inc.2011-07-25GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091594c90cdf38-2b2a-4d8c-a7b5-373787173193
3633230126ANDAApp Pharmaceuticals, Llc2011-05-16GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA090799c550dd16-a5e8-44be-87f2-210c15bbb513

26.3 ml gemcitabine 38 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090181NDAHospira, Inc.2011-08-04GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA200795dc02a23b-3ff9-4441-aa91-8e9e629a7315, e18ed1cb-7dd0-4001-bfda-17d1f4587fb8

5.26 ml gemcitabine 38 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090183NDAHospira, Inc.2011-08-04GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA200795dc02a23b-3ff9-4441-aa91-8e9e629a7315, e18ed1cb-7dd0-4001-bfda-17d1f4587fb8

52.6 ml gemcitabine 38 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090182NDAHospira, Inc.2011-08-04GEMCITABINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA200795dc02a23b-3ff9-4441-aa91-8e9e629a7315, e18ed1cb-7dd0-4001-bfda-17d1f4587fb8

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077983GEMCITABINE HYDROCHLORIDETEVA PHARMACEUTICALS USA2011-01-25ANDA077983_001, ANDA077983_002
2ANDA078339GEMCITABINE HYDROCHLORIDEHOSPIRA WORLDWIDE, INC2011-07-25ANDA078339_001, ANDA078339_002
3ANDA078433GEMCITABINE HYDROCHLORIDESUN PHARMA GLOBAL INC2011-07-25ANDA078433_001, ANDA078433_002
4ANDA078759GEMCITABINE HYDROCHLORIDECIPLA LTD2011-07-25ANDA078759_001, ANDA078759_002
5ANDA079160GEMCITABINE HYDROCHLORIDEACTAVIS TOTOWA LLC2011-07-25ANDA079160_001, ANDA079160_002
6ANDA079183GEMCITABINE HYDROCHLORIDEHOSPIRA INC2010-11-15ANDA079183_001
7ANDA090242GEMCITABINE HYDROCHLORIDEFRESENIUS KABI USA LLC2011-05-16ANDA090242_003
8ANDA090663GEMCITABINE HYDROCHLORIDEHAMELN RDS GMBH2012-09-10ANDA090663_001, ANDA090663_002
9ANDA090799GEMCITABINE HYDROCHLORIDEFRESENIUS KABI ONCOLOGY PLC2011-05-16ANDA090799_001, ANDA090799_002, ANDA090799_003
10ANDA091365GEMCITABINE HYDROCHLORIDEDR REDDYS LABORATORIES LTD2011-07-25ANDA091365_001, ANDA091365_002
11ANDA091594GEMCITABINE HYDROCHLORIDEACCORD HEALTHCARE INC2011-07-25ANDA091594_001, ANDA091594_002, ANDA091594_003
12ANDA091597GEMCITABINE HYDROCHLORIDESAGENT PHARMACEUTICALS INC2013-05-07ANDA091597_001, ANDA091597_002
13ANDA200145GEMCITABINE HYDROCHLORIDEMYLAN LABORATORIES LTD2011-07-25ANDA200145_001, ANDA200145_002, ANDA200145_003
14ANDA202031GEMCITABINE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC2013-05-07ANDA202031_001, ANDA202031_002
15ANDA202063GEMCITABINE HYDROCHLORIDEEMCURE PHARMACEUTICALS LTD2012-09-11ANDA202063_001, ANDA202063_002
16ANDA202485GEMCITABINE HYDROCHLORIDEJIANGSU HANSOH PHARMACEUTICAL CO LTD2013-05-07ANDA202485_001, ANDA202485_002
17ANDA202997GEMCITABINE HYDROCHLORIDEDR REDDYS LABORATORIES LTD2013-05-07ANDA202997_001
18NDA020509GEMZARELI LILLY AND CO1996-05-15NDA020509_001, NDA020509_002
19NDA200795GEMCITABINE HYDROCHLORIDEHOSPIRA INC2011-08-04NDA200795_001, NDA200795_002, NDA200795_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA077983_001RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-01-25GEMCITABINE HYDROCHLORIDE
2ANDA077983_002RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2011-01-25GEMCITABINE HYDROCHLORIDE
3ANDA078339_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
4ANDA078339_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
5ANDA078433_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
6ANDA078433_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
7ANDA078759_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
8ANDA078759_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
9ANDA079160_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
10ANDA079160_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
11ANDA079183_001RXGEMCITABINE HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONTrueAP2010-11-15GEMCITABINE HYDROCHLORIDE
12ANDA090242_003RXGEMCITABINE HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-05-16GEMCITABINE HYDROCHLORIDE
13ANDA090663_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2012-09-10GEMCITABINE HYDROCHLORIDE
14ANDA090663_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2012-09-10GEMCITABINE HYDROCHLORIDE
15ANDA090799_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
16ANDA090799_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
17ANDA090799_003RXGEMCITABINE HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-05-16GEMCITABINE HYDROCHLORIDE
18ANDA091365_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
19ANDA091365_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
20ANDA091594_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
21ANDA091594_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
22ANDA091594_003RXGEMCITABINE HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
23ANDA091597_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2013-05-07GEMCITABINE HYDROCHLORIDE
24ANDA091597_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2013-05-07GEMCITABINE HYDROCHLORIDE
25ANDA200145_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
26ANDA200145_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
27ANDA200145_003RXGEMCITABINE HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalseAP2011-07-25GEMCITABINE HYDROCHLORIDE
28ANDA202031_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2013-05-07GEMCITABINE HYDROCHLORIDE
29ANDA202031_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2013-05-07GEMCITABINE HYDROCHLORIDE
30ANDA202063_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2012-09-11GEMCITABINE HYDROCHLORIDE
31ANDA202063_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2012-09-11GEMCITABINE HYDROCHLORIDE
32ANDA202485_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONFalseAP2013-05-07GEMCITABINE HYDROCHLORIDE
33ANDA202485_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONFalseAP2013-05-07GEMCITABINE HYDROCHLORIDE
34ANDA202997_001RXGEMCITABINE HYDROCHLORIDE (EQ 2GM BASE/VIAL)INJECTIONFalseAP2013-05-07GEMCITABINE HYDROCHLORIDE
35NDA020509_001RXGEMCITABINE HYDROCHLORIDE (EQ 200MG BASE/VIAL)INJECTIONTrueAP1996-05-15GEMZAR
36NDA020509_002RXGEMCITABINE HYDROCHLORIDE (EQ 1GM BASE/VIAL)INJECTIONTrueAP1996-05-15GEMZAR
37NDA200795_001RXGEMCITABINE HYDROCHLORIDE (200MG/5.26ML)INJECTIONTrue2011-08-04GEMCITABINE HYDROCHLORIDE
38NDA200795_002RXGEMCITABINE HYDROCHLORIDE (1GM/26.3ML)INJECTIONTrue2011-08-04GEMCITABINE HYDROCHLORIDE
39NDA200795_003RXGEMCITABINE HYDROCHLORIDE (2GM/52.6ML)INJECTIONTrue2011-08-04GEMCITABINE HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11eeacf1b-0d89-4cfa-956d-dcb5880b431b (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection USP safely and effectively. See full prescribing information for Gemcitabine for Injection USP. GEMCITABINE for injection USP, powder, lyophilized, for solution, for intravenous use Initial U.S. Approval: 1996prescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-06-3016459630612, 459630619
244bcc16c-341d-49e8-a1c6-95d084667aca (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection, USP safely and effectively. See full prescribing information for Gemcitabine for Injection, USP. Gemcitabine for Injection, USP, Powder, Lyophilized, For Solution, For Intravenous Use Initial U.S. Approval: 1996prescriptionHuman PrescriptionSagent Pharmaceuticals2014-09-292250210234, 250210235
349f9e774-52f9-40af-aecf-217c11e243ce (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection USP safely and effectively. See full prescribing information for Gemcitabine for Injection USP.Gemcitabine for Injection USP, Powder, Lyophilized, For Solution For Intravenous UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-06-1411231550213, 231550214
46004fba9-49c0-4781-8134-44bf7cf196fd (view SPL)These highlights do not include all the information needed to use gemcitabine for injection, USP safely and effectively. See full prescribing information for gemcitabine for injection, USP . Gemcitabine for Injection, USP, Powder, Lyophilized, For Solution For Intravenous Use Initial U.S. Approval: 1996prescriptionHuman PrescriptionWatson Laboratories, Inc.MANUFACTURE2011-04-016005913562, 005913563
56087be15-56c1-4794-b159-ad9082b631b9 (view SPL)These highlights do not include all the information needed to use gemcitabine safely and effectively. See full prescribing information forgemcitabine.GEMCITABINE for injection USP,for intravenous use Initial U.S. Approval: 1996prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-05-075473350153, 473350154
6632a8105-9cb2-44ba-8c10-2a1efd6ac960 (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection safely and effectively. See full prescribing information for Gemcitabine for Injection. Gemcitabine for Injection, Powder, Lyophilized, For Solution For Intravenous UseInitial U.S. Approval:2011prescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture2011-07-131000693857
781399444-3a4f-4a22-ab1d-b99896f3a211 (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection USP safely and effectively. See full prescribing information for Gemcitabine for Injection USP.Gemcitabine for Injection USP, Powder, Lyophilized, For Solution For Intravenous UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-06-241231550483
89dc35c59-f4f3-43b4-8251-0cf5c06cdc80 (view SPL)These highlights do not include all the information needed to use Gemzar safely and effectively. See full prescribing information for Gemzar.GEMZAR (gemcitabine for injection), for intravenous useInitial U.S. Approval: 1996prescriptionHuman PrescriptionEli Lilly And Company2014-06-1018000027501, 000027502
9a625c92b-c569-4b98-8d2e-2b3f5e12b34f (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection, USP safely and effectively. See full prescribing information for Gemcitabine for Injection, USP.Gemcitabine (gemcitabine hydrochloride) for Injection, Powder, Lyophilized, For Solution For Intravenous Use Initial U.S. Approval: 1996prescriptionHuman PrescriptionHospira, Inc.2015-05-1816004090187
10ba288004-daec-4b80-9041-cc72c63ba2c4 (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection USP safely and effectively. See full prescribing information for Gemcitabine for Injection USP.Gemcitabine for Injection USP (gemcitabine for injection) Powder, Lyophilized, For SolutionFor Intravenous Use Initial U.S. Approval: 1996prescriptionHuman PrescriptionHameln Rds GmbhANALYSIS, MANUFACTURE2012-09-153422360001, 422360002
11c550dd16-a5e8-44be-87f2-210c15bbb513 (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection, USP safely and effectively. See full prescribing information for Gemcitabine for Injection, USP.Gemcitabine for Injection, USP, Powder, Lyophilized, For Solution For Intravenous UseInitial U.S. Approval:1996prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-03-0210633230102, 633230125, 633230126
12c90cdf38-2b2a-4d8c-a7b5-373787173193 (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection safely and effectively. See full prescribing information for Gemcitabine for Injection. Gemcitabine for injection, Powder, Lyophilized, For Solution For Intravenous Use Initial U.S. Approval: 1996prescriptionHuman PrescriptionAccord Healthcare Inc.ANALYSIS, manufacture2014-08-045167290092, 167290117, 167290118
13cebd1bac-f2a2-46f2-ac5c-021a46bfcc9b (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection USP safely and effectively. See full prescribing information for Gemcitabine for Injection USP.Gemcitabine for Injection USP, Powder, Lyophilized, For Solution For Intravenous UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-07-012231550528
14d16907e7-a8c8-4039-ace4-cf4e24ba68c0 (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection, USP safely and effectively. See full prescribing information for Gemcitabine for Injection, USP.Gemcitabine (gemcitabine hydrochloride) for Injection, Powder, Lyophilized, For Solution For Intravenous Use Initial U.S. Approval: 1996prescriptionHuman PrescriptionHospira, Inc.2015-05-1816004090185, 004090186
15dc02a23b-3ff9-4441-aa91-8e9e629a7315 (view SPL)These highlights do not include all the information needed to use Gemcitabine Injection safely and effectively. See full prescribing information for Gemcitabine Injection. GEMCITABINE INJECTION For Intravenous Infusion Only. Must Be Diluted Before Use. Initial U.S. Approval: 1996prescriptionHuman PrescriptionHospira, Inc.2014-05-0813004090181, 004090182, 004090183
16e18ed1cb-7dd0-4001-bfda-17d1f4587fb8 (view SPL)These highlights do not include all the information needed to use Gemcitabine Injection safely and effectively. See full prescribing information for Gemcitabine Injection. GEMCITABINE INJECTION For Intravenous Infusion Only. Must Be Diluted Before Use. Initial U.S. Approval: 1996prescriptionHuman PrescriptionHospira, Inc.2014-05-122004090181, 004090182, 004090183
17eafcebc8-ddef-bb6b-fd0a-9d8b9962cdc4 (view SPL)These highlights do not include all the information needed to use gemcitabine for injection safely and effectively. See full prescribing information for gemcitabine for injection. Gemcitabine For Injection, Powder, Lyophilized, For Solution For Intravenous Use Initial U.S. Approval: 1996prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdmanufacture2014-05-1410551110686, 551110687
18fdf52dca-732c-4a1a-9475-e9e1e3af4ce8 (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection safely and effectively. See full prescribing information for Gemcitabine for Injection. GEMCITABINE for Injection, USP Powder, lyophilized, for solution for intravenous useInitial U.S. Approval:1996prescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-05-282674570464
19ffc0a4be-6091-4157-837e-3637c1e121a6 (view SPL)These highlights do not include all the information needed to use Gemcitabine for Injection, USP safely and effectively. See full prescribing information for Gemcitabine for Injection, USP. Gemcitabine for Injection, USP, Powder, Lyophilized, For Solution, For Intravenous Use Initial U.S. Approval: 1996prescriptionHuman PrescriptionSagent Pharmaceuticals2013-08-227250210208, 250210209

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