Granisetron Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2015-09-22)
Oldest Current Product
2007-12-31
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\GRANISETRON
FDAOB
INJECTION\INJECTION\GRANISETRON HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\GRANISETRON HYDROCHLORIDE
INTRAVENOUS\INJECTION\GRANISETRON HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\GRANISETRON
INTRAVENOUS\INJECTION\GRANISETRON

product(s) by strength(s)

granisetron 0.1 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1174780547ANDAAkorn2009-10-01GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA07911902f350c9-b7d2-4906-af28-70ed4461ff23
2250210778ANDASagent Pharmaceuticals2010-12-01, 2013-05-31GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA091136854f36f4-f4db-472a-b984-cdd16d1916c8, a488b4fe-4cdf-42ad-a328-0b0c4bdf09ea
3556480662ANDAWockhardt Limited2008-03-03GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA078566a43da9a3-1997-40d9-8622-97490a5c0642
4633230317ANDAApp Pharmaceuticals, Llc2009-11-20GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA078522dddc8714-383f-4bc5-a468-ae89dbc802b4
5646790662ANDAWockhardt Usa Llc.2008-03-03GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA078566cb583779-2746-4363-9cf7-f198247188d1
6690970195ANDACipla Usa Inc.2007-12-31GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA0782629da1db8c-761e-4d97-b1c1-297a4b0f0c5f

granisetron 1 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439744ANDAWest-Ward Pharmaceutical Corp2009-12-23GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA078629e07862df-f324-4575-a1ef-f7e1cbab4c7a
2001439745ANDAWest-Ward Pharmaceutical Corp2009-12-23GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA078629e07862df-f324-4575-a1ef-f7e1cbab4c7a
3174780546ANDAAkorn2009-10-01GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA07907802f350c9-b7d2-4906-af28-70ed4461ff23
4250210779ANDASagent Pharmaceuticals2010-12-01GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA091136854f36f4-f4db-472a-b984-cdd16d1916c8
5250210781ANDASagent Pharmaceuticals2010-12-01GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA09113771fb4680-55f4-4058-8559-0b08a2a2d0ed
6556480661ANDAWockhardt Limited2008-06-30GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA078564, ANDA078565af68579f-c863-4535-94af-a4126b43c182, fb723c47-002e-4243-9c5e-448f5cfd6d68
7633230318ANDAApp Pharmaceuticals, Llc2009-11-20GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA078096dddc8714-383f-4bc5-a468-ae89dbc802b4
8633230319ANDAApp Pharmaceuticals, Llc2009-11-20GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA078090dddc8714-383f-4bc5-a468-ae89dbc802b4
9646790661ANDAWockhardt Usa Llc.2008-06-30GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA078564, ANDA078565a9474607-7949-410b-a10a-4a9bd4148783, eadac0ab-0eb5-4cd7-bb3d-411d712b54f8
10667580035ANDASandoz Inc2008-06-30GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA0788352eb798cf-f480-408d-8feb-73f4f943e884
11667580036ANDASandoz Inc2008-06-30GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA0788352eb798cf-f480-408d-8feb-73f4f943e884
12690970196ANDACipla Usa Inc.2008-06-30GRANISETRON HYDROCHLORIDEINTRAVENOUSINJECTIONANDA0782586668f8ad-0d6a-4ce3-8808-53165de3ad9b

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA077165GRANISETRON HYDROCHLORIDE PRESERVATIVE FREETrueTEVA PHARMACEUTICALS USA2007-12-31ANDA077165_001
2ANDA077177GRANISETRON HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2007-12-31ANDA077177_001
3ANDA077186GRANISETRON HYDROCHLORIDEBEDFORD LABORATORIES2008-06-30ANDA077186_001
4ANDA077187GRANISETRON HYDROCHLORIDEBEDFORD LABORATORIES2008-06-30ANDA077187_001
5ANDA077297GRANISETRON HYDROCHLORIDETEVA PHARMACEUTICALS USA2008-06-30ANDA077297_001
6ANDA077913GRANISETRON HYDROCHLORIDEBEDFORD LABORATORIES2008-06-26ANDA077913_001
7ANDA077963GRANISETRON HYDROCHLORIDETEVA PHARMACEUTICALS USA2008-01-03ANDA077963_001
8ANDA078090GRANISETRON HYDROCHLORIDEFRESENIUS KABI USA LLC2008-06-30ANDA078090_001
9ANDA078096GRANISETRON HYDROCHLORIDE PRESERVATIVE FREEFRESENIUS KABI USA LLC2008-06-30ANDA078096_001
10ANDA078197GRANISETRON HYDROCHLORIDETrueAPOTEX INC2007-12-31ANDA078197_001
11ANDA078198GRANISETRON HYDROCHLORIDETrueCLARIS PHARMASERVICES2008-06-30ANDA078198_001, ANDA078198_002
12ANDA078258GRANISETRON HYDROCHLORIDECIPLA LTD2008-06-30ANDA078258_001, ANDA078258_002
13ANDA078262GRANISETRON HYDROCHLORIDECIPLA LTD2007-12-31ANDA078262_001
14ANDA078392GRANISETRON HYDROCHLORIDETEVA PHARMACEUTICALS USA2007-12-31ANDA078392_001
15ANDA078522GRANISETRON HYDROCHLORIDEFRESENIUS KABI USA LLC2007-12-31ANDA078522_001
16ANDA078531GRANISETRON HYDROCHLORIDESANDOZ CANADA INC2009-04-30ANDA078531_001, ANDA078531_002
17ANDA078534GRANISETRON HYDROCHLORIDESANDOZ CANADA INC2009-04-30ANDA078534_001
18ANDA078564GRANISETRON HYDROCHLORIDEWOCKHARDT USA INC2008-06-30ANDA078564_001
19ANDA078565GRANISETRON HYDROCHLORIDEWOCKHARDT USA INC2008-06-30ANDA078565_001
20ANDA078566GRANISETRON HYDROCHLORIDEWOCKHARDT USA INC2008-02-29ANDA078566_001
21ANDA078629GRANISTERON HYDROCHLORIDEHIKMA FARMACEUTICA (PORTUGAL) SA2009-12-23ANDA078629_001, ANDA078629_002
22ANDA078808GRANISETRON HYDROCHLORIDETrueSANDOZ INC2008-04-29ANDA078808_001
23ANDA078835GRANISETRON HYDROCHLORIDESANDOZ INC2008-06-30ANDA078835_001, ANDA078835_002
24ANDA078863GRANISETRON HYDROCHLORIDEBANNER LIFE SCIENCES LLC2008-06-30ANDA078863_001, ANDA078863_002
25ANDA078880GRANISETRON HYDROCHLORIDEBANNER LIFE SCIENCES LLC2008-06-30ANDA078880_001
26ANDA079078GRANISETRON HYDROCHLORIDEAKORN INC2009-09-14ANDA079078_001, ANDA079078_002
27ANDA079119GRANISETRON HYDROCHLORIDEAKORN INC2009-09-10ANDA079119_001
28ANDA091136GRANISETRON HYDROCHLORIDESAGENT STRIDES LLC2010-04-09ANDA091136_001, ANDA091136_002
29ANDA091137GRANISETRON HYDROCHLORIDESAGENT AGILA LLC2010-04-09ANDA091137_002
30ANDA091274GRANISETRON HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC2010-09-22ANDA091274_001
31NDA020239KYTRILTrueHOFFMANN LA ROCHE INC1993-12-29p5952340, POST OPERATIVE NAUSEA AND VOMITINGNDA020239_001, NDA020239_002, NDA020239_003, NDA020239_004

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA077165_001discontinuedGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse2007-12-31GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
2ANDA077177_001RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2007-12-31GRANISETRON HYDROCHLORIDE
3ANDA077186_001RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
4ANDA077187_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
5ANDA077297_001RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONTrueAP2008-06-30GRANISETRON HYDROCHLORIDE
6ANDA077913_001RXGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2008-06-26GRANISETRON HYDROCHLORIDE
7ANDA077963_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONTrueAP2008-01-03GRANISETRON HYDROCHLORIDE
8ANDA078090_001RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
9ANDA078096_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONTrueAP2008-06-30GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
10ANDA078197_001discontinuedGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalse2007-12-31GRANISETRON HYDROCHLORIDE
11ANDA078198_001discontinuedGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse2008-06-30GRANISETRON HYDROCHLORIDE
12ANDA078198_002discontinuedGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalse2008-06-30GRANISETRON HYDROCHLORIDE
13ANDA078258_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
14ANDA078258_002RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
15ANDA078262_001RXGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2007-12-31GRANISETRON HYDROCHLORIDE
16ANDA078392_001RXGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONTrueAP2007-12-31GRANISETRON HYDROCHLORIDE
17ANDA078522_001RXGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2007-12-31GRANISETRON HYDROCHLORIDE
18ANDA078531_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2009-04-30GRANISETRON HYDROCHLORIDE
19ANDA078531_002RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2009-04-30GRANISETRON HYDROCHLORIDE
20ANDA078534_001RXGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2009-04-30GRANISETRON HYDROCHLORIDE
21ANDA078564_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
22ANDA078565_001RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
23ANDA078566_001RXGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2008-02-29GRANISETRON HYDROCHLORIDE
24ANDA078629_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2009-12-23GRANISTERON HYDROCHLORIDE
25ANDA078629_002RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2009-12-23GRANISTERON HYDROCHLORIDE
26ANDA078808_001discontinuedGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalse2008-04-29GRANISETRON HYDROCHLORIDE
27ANDA078835_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
28ANDA078835_002RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
29ANDA078863_001RXGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
30ANDA078863_002RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
31ANDA078880_001RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2008-06-30GRANISETRON HYDROCHLORIDE
32ANDA079078_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2009-09-14GRANISETRON HYDROCHLORIDE
33ANDA079078_002RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2009-09-14GRANISETRON HYDROCHLORIDE
34ANDA079119_001RXGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2009-09-10GRANISETRON HYDROCHLORIDE
35ANDA091136_001RXGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalseAP2010-04-09GRANISETRON HYDROCHLORIDE
36ANDA091136_002RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2010-04-09GRANISETRON HYDROCHLORIDE
37ANDA091137_002RXGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalseAP2010-04-09GRANISETRON HYDROCHLORIDE
38ANDA091274_001RXGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalseAP2010-09-22GRANISETRON HYDROCHLORIDE
39NDA020239_001discontinuedGRANISETRON HYDROCHLORIDE (EQ 3MG BASE/ML)INJECTIONFalse1993-12-29KYTRIL
40NDA020239_002discontinuedGRANISETRON HYDROCHLORIDE (EQ 4MG BASE/4ML)INJECTIONFalse1994-03-11KYTRIL
41NDA020239_003discontinuedGRANISETRON HYDROCHLORIDE (EQ 0.1MG BASE/ML)INJECTIONFalse2004-09-17KYTRIL
42NDA020239_004discontinuedGRANISETRON HYDROCHLORIDE (EQ 1MG BASE/ML)INJECTIONFalse1994-03-11KYTRIL

patent(s)

#idexpiration dateapplication(s)
1p5952340 (view patent)2016-09-14NDA020239

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102f350c9-b7d2-4906-af28-70ed4461ff23 (view SPL)These highlights do not include all the information needed to use GRANISETRON HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for GRANISETRON HYDROCHLORIDE INJECTION, USP.GRANISETRON HYDROCHLORIDE injection USP, for intravenous useInitial U.S. Approval: 1993prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-09-228174780546, 174780547
22eb798cf-f480-408d-8feb-73f4f943e884 (view SPL)These highlights do not include all the information needed to use GRANISETRON HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for GRANISETRON HYDROCHLORIDE INJECTION, USP.GRANISETRON HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionSandoz Inc2015-08-2416667580035, 667580036
36668f8ad-0d6a-4ce3-8808-53165de3ad9b (view SPL)These highlights do not include all the information needed to use GRANISETRON hydrochloride injection safely and effectively. See full prescribing information for GRANISETRON hydrochloride injection. GRANISETRON hydrochloride injection, for intravenous use. Initial U.S. Approval:1993prescriptionHuman PrescriptionCipla Usa Inc.manufacture2015-07-283690970196
471fb4680-55f4-4058-8559-0b08a2a2d0ed (view SPL)These highlights do not include all the information needed to use granisetron hydrochloride safely and effectively. See full prescribing information for granisetron hydrochloride. GRANISETRON hydrochloride injection, USP, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionSagent Pharmaceuticals2014-11-0616250210781
5854f36f4-f4db-472a-b984-cdd16d1916c8 (view SPL)These highlights do not include all the information needed to use granisetron hydrochloride safely and effectively. See full prescribing information for granisetron hydrochloride.GRANISETRON hydrochloride injection, USP, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionSagent Pharmaceuticals2014-11-0615250210778, 250210779
69da1db8c-761e-4d97-b1c1-297a4b0f0c5f (view SPL)These highlights do not include all the information needed to use GRANISETRON hydrochloride injection safely and effectively. See full prescribing information for GRANISETRON hydrochloride injection. GRANISETRON hydrochloride injection, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionCipla Usa Inc.Manufacture2014-10-063690970195
7a43da9a3-1997-40d9-8622-97490a5c0642 (view SPL)These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. Granisetron Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionWockhardt Limitedmanufacture2011-11-291556480662
8a488b4fe-4cdf-42ad-a328-0b0c4bdf09ea (view SPL)These highlights do not include all the information needed to use granisetron hydrochloride safely and effectively. See full prescribing information for granisetron hydrochloride.GRANISETRON hydrochloride injection, USP, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionSagent Pharmaceuticals2014-11-194250210778
9a9474607-7949-410b-a10a-4a9bd4148783 (view SPL)These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. Granisetron Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionWockhardt Usa Llc.manufacture2011-12-022646790661
10af68579f-c863-4535-94af-a4126b43c182 (view SPL)These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. Granisetron Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionWockhardt Limitedmanufacture2011-12-202556480661
11cb583779-2746-4363-9cf7-f198247188d1 (view SPL)These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. Granisetron Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionWockhardt Usa Llc.manufacture2011-11-291646790662
12dddc8714-383f-4bc5-a468-ae89dbc802b4 (view SPL)These highlights do not include all the information needed to use GRANISETRON HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for GRANISETRON HYDROCHLORIDE INJECTION, USP. GRANISETRON HYDROCHLORIDE INJECTION, USP for Intravenous UseInitial U.S. Approval: 1993prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-05-315633230317, 633230318, 633230319
13e07862df-f324-4575-a1ef-f7e1cbab4c7a (view SPL)These highlights do not include all the information needed to use Granisetron Hydrochloride Injection, USP safely and effectively. See full prescribing information for Granisetron Hydrochloride Injection, USP. GRANISETRON hydrochloride injection, USP for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-03-267001439744, 001439745
14eadac0ab-0eb5-4cd7-bb3d-411d712b54f8 (view SPL)These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. Granisetron Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionWockhardt Usa Llc.manufacture2011-12-071646790661
15fb723c47-002e-4243-9c5e-448f5cfd6d68 (view SPL)These highlights do not include all the information needed to use granisetron hydrochloride injection safely and effectively. See full prescribing information for granisetron hydrochloride injection. Granisetron Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionWockhardt Limitedmanufacture2011-12-071556480661

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