Ondansetron Injectable Solution

Brand(s)
Zofran
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Heritage Pharmaceuticals Inc. (2015-11-09)
Oldest Current Product
1991-02-04
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\ONDANSETRON
FDAOB
INJECTION\INJECTION\ONDANSETRON HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\ONDANSETRON HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\ONDANSETRON HYDROCHLORIDE
INTRAMUSCULAR\SOLUTION\ONDANSETRON HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\ONDANSETRON HYDROCHLORIDE
INTRAVENOUS\INJECTION\ONDANSETRON HYDROCHLORIDE
INTRAVENOUS\SOLUTION\ONDANSETRON HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\ONDANSETRON
INTRAMUSCULAR\INJECTION\ONDANSETRON
INTRAMUSCULAR\SOLUTION\ONDANSETRON
INTRAVENOUS\INJECTION, SOLUTION\ONDANSETRON
INTRAVENOUS\INJECTION\ONDANSETRON
INTRAVENOUS\SOLUTION\ONDANSETRON

product(s) by strength(s)

ondansetron 0.64 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690700ANDAPfizer Labs2009-05-01ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA0783082a09af01-3983-466f-8ed8-c849af848b56
2001439771ANDAWest-Ward Pharmaceutical Corp2009-08-04ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA078308693ba38b-4cbe-4a6a-9c80-b9d2f554edce
3360000014ANDAClaris Lifesciences Inc.2009-04-14ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA078308d931b294-8834-4c7f-ac05-9aeb078cd86e

ondansetron 2 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730442ZofranNDAGlaxosmithkline Llc1991-02-04ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONNDA020007d9a71b42-ddfc-49d5-7280-0fc0041dba41

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000691340ANDAPfizer Labs2011-05-10ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA078244, ANDA078257302da2e0-3538-42fd-b712-45725a790fb0, c851ac17-0068-4320-94d4-fd955a26e1ac
2000691441ANDAPfizer Labs2013-05-04ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA079224, ANDA0906480b658a68-eb03-48dc-bf0b-bbc417f318fc, 8f09046c-06a7-4141-8e48-d720e46a68b0
3001439890ANDAWest-Ward Pharmaceutical Corp2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA076781bb4bc810-db26-471b-9ce7-6e2fb3018af0
4001439891ANDAWest-Ward Pharmaceutical Corp2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA076780bb4bc810-db26-471b-9ce7-6e2fb3018af0
5004094755ANDAHospira, Inc.2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0775486a11f61b-2318-4382-2b91-4366e4bb53fa
6004094759ANDAHospira, Inc.2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0774736a11f61b-2318-4382-2b91-4366e4bb53fa
7006416078ANDAWest-Ward Pharmaceuticals Corp.2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA077541c29ca6df-621d-44b6-98fc-b48666573366
8006416079ANDAWest-Ward Pharmaceuticals Corp.2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA077365c29ca6df-621d-44b6-98fc-b48666573366
9006416080ANDAWest-Ward Pharmaceuticals Corp.2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA07754197713356-f42b-4a67-95f6-561afa68c0c2
10007037221ANDATeva Parenteral Medicines, Inc2006-11-22ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA076759d0360f27-1ca3-4995-b277-28091ac388fc
11007037226ANDATeva Parenteral Medicines, Inc2006-11-22ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA076876d787900f-f617-478d-a65b-eef170e929f9
12007813010ANDASandoz Inc2007-06-27ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA07755142abd7f6-d3b0-4133-b9ca-258f699f7162
13100190905ANDABaxter Healthcare Corporation2010-11-19ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA077541f927b041-1d05-478c-ac26-066d9c782c5e
14100190906ANDABaxter Healthcare Corporation2010-11-19ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA077365f927b041-1d05-478c-ac26-066d9c782c5e
15231550168ANDAHeritage Pharmaceuticals Inc.2012-12-13ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA090424f1395040-4d33-4db3-aeb7-6aeda172b77f
16231550196ANDAHeritage Pharmaceuticals Inc.2013-01-18ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA078945ff42153c-9c0e-40e0-b21c-376010548dcc
17231550377ANDAHeritage Pharmaceuticals Inc.2014-02-24ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA0904243784d6b8-ce99-4e96-aa73-b8f4c679f741
18231550378ANDAHeritage Pharmaceuticals Inc.2014-02-19ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA078945f1003333-104c-44bd-9c60-56f22ee4f955
19231550547ANDAHeritage Pharmaceuticals Inc.2012-06-15ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA079224b746d4db-43e6-4219-9e6b-f53e59581305
20231550548ANDAHeritage Pharmaceuticals Inc.2015-11-09ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA0792248cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08
21231550549ANDAHeritage Pharmaceuticals Inc.2012-06-15ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA090648b746d4db-43e6-4219-9e6b-f53e59581305
22231550550ANDAHeritage Pharmaceuticals Inc.2015-11-09ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA0906488cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08
23250210777ANDASagent Pharmaceuticals2012-08-30ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA079224ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7
24250210782ANDASagent Pharmaceuticals2012-08-30ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA090648ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7
25360000012ANDAClaris Lifesciences Inc.2013-03-13ONDANSETRON HYDROCHLORIDEINTRAMUSCULARSOLUTIONANDA078287729d865f-d84a-495e-9456-4bceebb6e03f
26360000013ANDAClaris Lifesciences Inc.2013-03-13ONDANSETRON HYDROCHLORIDEINTRAMUSCULARSOLUTIONANDA078288729d865f-d84a-495e-9456-4bceebb6e03f
27551500125ANDAAuromedics Pharma Llc2012-12-21ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA20260076237ed8-cbee-4371-a1b7-623a714fed11
28551500126ANDAAuromedics Pharma Llc2012-12-21ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA2025991cc94c7a-617c-4238-8248-e3fabc9612c7
29556480726ANDAWockhardt Limited2006-12-27ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA077716bf5cbf1b-af47-419e-bc32-6d6b94a785b5
30556480727ANDAWockhardt Limited2006-12-27ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA077577bf5cbf1b-af47-419e-bc32-6d6b94a785b5
31627560181ANDASun Pharmaceutical Industries Limited2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA0771736e76d0ef-93ca-4be9-8384-65656fe8bd47
32627560182ANDASun Pharmaceutical Industries Limited2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA0771726e76d0ef-93ca-4be9-8384-65656fe8bd47
33633230373ANDAApp Pharmaceuticals, Llc2009-11-18ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA076972e0050959-c14c-41b6-9a92-fadc5f6feff3
34633230374ANDAApp Pharmaceuticals, Llc2009-11-18ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA076974e0050959-c14c-41b6-9a92-fadc5f6feff3
35646790726ANDAWockhardt Usa Llc.2006-12-27ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA077716a194b8f8-163c-4e48-bc8b-871391010bab
36646790727ANDAWockhardt Usa Llc.2006-12-27ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA077577a194b8f8-163c-4e48-bc8b-871391010bab
37652930373ANDAThe Medicines Company2009-11-18ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA076972dc3dc0e4-b7da-4da4-afa6-d57e4ee42339
38652930374ANDAThe Medicines Company2009-11-18ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA076974dc3dc0e4-b7da-4da4-afa6-d57e4ee42339
39671840507ANDAQilu Pharmaceutical Co., Ltd.2014-09-08ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA2037115e09e262-dadf-4ae0-825e-448ea8dac174
40674570440ANDAMylan Institutional Llc2014-12-29ONDANSETRON HYDROCHLORIDEINTRAMUSCULARSOLUTIONANDA079224fa8c2931-35a7-4b4b-8be2-eda701b51079
41674570441ANDAMylan Institutional Llc2014-12-29ONDANSETRON HYDROCHLORIDEINTRAMUSCULARSOLUTIONANDA090648fa8c2931-35a7-4b4b-8be2-eda701b51079
42680830113ANDAGland Pharma Limited2009-09-25ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA0792243efa5604-96c3-42a0-8e99-b3de4a66aa92
43680830114ANDAGland Pharma Limited2012-06-15ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA09064835716914-ac73-43c0-9aa0-09c99211d941

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271726ANDALannett Company, Inc.2010-07-01ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA090116be5930d2-0008-4e61-9715-684c29a9c613

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250334ANDARemedyrepack Inc.2013-06-14, 2013-09-27, 2013-11-25ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004094755ANDA0775487a6b44e7-afe0-480e-b84a-425d4295e123, 8e295c24-75d9-4728-86f8-a6375425f923, cc6b5e2c-ae2a-4ec1-aa10-f8c85b3b3030, d89ebc98-933a-4fa7-9ac7-6046b6dddd13
2521250574ANDARemedyrepack Inc.2013-07-05, 2013-11-25, 2013-12-05ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION646790726ANDA07771640fda14c-22f4-40ad-af64-5c637853b766, 5bc2c91c-4192-4091-a677-ab24218c54dc, 5eb3c741-f3af-4059-879a-732857488021
3521250744ANDARemedyrepack Inc.2013-10-14, 2013-11-25, 2013-12-17ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION007813010ANDA07755128e68c9e-b23d-4769-a880-17a95ff3fc5e, 52a5f6b5-c35d-4966-9f87-38af278a4744, 5676fab0-b575-443a-8c67-656259d60264, f21c82e6-8660-4e00-a1fa-7db803868a14
4521250809ANDARemedyrepack Inc.2014-01-09ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION007037221ANDA0767596fe526f8-4e2b-4a74-b31f-306038d5e6c0
5521250834ANDARemedyrepack Inc.2014-02-13ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION551500125ANDA202600a28ed7cd-2c67-4953-a6ca-3dc276c2cfff
6521250983ANDARemedyrepack Inc.2014-07-07, 2014-10-20ONDANSETRON HYDROCHLORIDEINTRAVENOUSSOLUTION360000012ANDA0782875d18f175-b283-4316-bb44-287d0668e557, e8b042ef-b5ef-47c0-adea-b82a094fee0c
7548685888ANDAPhysicians Total Care, Inc.2008-05-08ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION627780027ANDA076781a360d43c-bed8-4f41-ab36-e2aa77dfbff2
8551542872ANDACardinal Health2010-11-19ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION100190905ANDA077541d337b07d-5d72-428d-ac31-d8afbfd3b44b
9551542873ANDACardinal Health2010-11-19ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION100190905ANDA077541d337b07d-5d72-428d-ac31-d8afbfd3b44b
10551542876ANDACardinal Health2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION006416080ANDA077541ee1f115f-c8f8-4526-b827-c8e48aeb5050
11551542877ANDACardinal Health2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION006416078ANDA07754161758670-91ab-4422-8d9d-e8ca87eecae8
12551544731ANDACardinal Health2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004094755ANDA077548b1089917-f63a-4031-a43a-e8c0b87c2849
13551546976ANDACardinal Health2006-12-26ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004094755ANDA0775481b9c2d9f-62a8-4d26-a041-a598bc59e300
14551548329ANDACardinal Health2012-12-21ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION551500125ANDA202600758b42d4-811e-4e30-823e-bcfd85800065
15617860435ANDARemedyrepack Inc.2015-10-19ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004094755ANDA077548993c5307-8054-4b2d-a013-6a70ebe77b5c

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA076695ONDANSETRON HYDROCHLORIDETrueHOSPIRA INC2006-12-26ANDA076695_001Ondansetron Prefilled Syringe
2ANDA076696ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREETrueHOSPIRA INC2006-12-26ANDA076696_001Ondansetron Prefilled Syringe
3ANDA076759ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREETEVA PHARMACEUTICALS USA INC2006-11-22ANDA076759_001Ondansetron Prefilled Syringe
4ANDA076780ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEHIKMA FARMACEUTICA (PORTUGAL) SA2006-12-26ANDA076780_001Ondansetron Prefilled Syringe
5ANDA076781ONDANSETRON HYDROCHLORIDEHIKMA FARMACEUTICA (PORTUGAL) SA2006-12-26ANDA076781_001Ondansetron Prefilled Syringe
6ANDA076876ONDANSETRON HYDROCHLORIDETEVA PHARMACEUTICALS USA INC2006-11-22ANDA076876_001Ondansetron Prefilled Syringe
7ANDA076967ONDANSETRON HYDROCHLORIDEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2006-12-26ANDA076967_001Ondansetron Prefilled Syringe
8ANDA076972ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEFRESENIUS KABI USA LLC2006-12-26ANDA076972_001Ondansetron Prefilled Syringe
9ANDA076974ONDANSETRON HYDROCHLORIDEFRESENIUS KABI USA LLC2006-12-26ANDA076974_001Ondansetron Prefilled Syringe
10ANDA076978ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINERTrueHOSPIRA INC2007-02-26ANDA076978_001Ondansetron Prefilled Syringe
11ANDA077011ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEBEDFORD LABORATORIES2006-12-26ANDA077011_001Ondansetron Prefilled Syringe
12ANDA077172ONDANSETRON HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES LTD2006-12-26ANDA077172_001Ondansetron Prefilled Syringe
13ANDA077173ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREESUN PHARMACEUTICAL INDUSTRIES LTD2006-12-26ANDA077173_001Ondansetron Prefilled Syringe
14ANDA077343ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREETrueAPOTEX INC2006-12-26ANDA077343_001Ondansetron Prefilled Syringe
15ANDA077365ONDANSETRON HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2006-12-26ANDA077365_001Ondansetron Prefilled Syringe
16ANDA077368ONDANSETRON HYDROCHLORIDETrueAPOTEX INC2006-12-26ANDA077368_001Ondansetron Prefilled Syringe
17ANDA077387ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREETrueLUITPOLD PHARMACEUTICALS INC2006-12-26ANDA077387_001Ondansetron Prefilled Syringe
18ANDA077430ONDANSETRON HYDROCHLORIDESANDOZ CANADA INC2007-06-27ANDA077430_001Ondansetron Prefilled Syringe
19ANDA077473ONDANSETRON HYDROCHLORIDEHOSPIRA INC2006-12-26ANDA077473_001Ondansetron Prefilled Syringe
20ANDA077541ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEUROHEALTH INTERNATIONAL SARL2006-12-26ANDA077541_001Ondansetron Prefilled Syringe
21ANDA077544ONDANSETRON HYDROCHLORIDETruePLIVA HRVATSKA DOO2006-12-26ANDA077544_001Ondansetron Prefilled Syringe
22ANDA077548ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEHOSPIRA INC2006-12-26ANDA077548_001Ondansetron Prefilled Syringe
23ANDA077551ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREESANDOZ CANADA INC2007-06-27ANDA077551_001Ondansetron Prefilled Syringe
24ANDA077577ONDANSETRON HYDROCHLORIDEWOCKHARDT LTD2006-12-26ANDA077577_001Ondansetron Prefilled Syringe
25ANDA077582ONDANSETRON HYDROCHLORIDETrueLUITPOLD PHARMACEUTICALS INC2006-12-26ANDA077582_001Ondansetron Prefilled Syringe
26ANDA077716ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEWOCKHARDT LTD2006-12-26ANDA077716_001Ondansetron Prefilled Syringe
27ANDA077840ONDANSETRON HYDROCHLORIDEHOSPIRA INC2007-01-19ANDA077840_001Ondansetron Prefilled Syringe
28ANDA078014ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREETrueTARO PHARMACEUTICALS IRELAND LTD2008-03-21ANDA078014_001Ondansetron Prefilled Syringe
29ANDA078180ONDANSETRON HYDROCHLORIDETrueSAGENT PHARMACEUTICALS INC2007-03-26ANDA078180_001Ondansetron Prefilled Syringe
30ANDA078244ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEMYLAN LABORATORIES LTD2008-04-23ANDA078244_001Ondansetron Prefilled Syringe
31ANDA078257ONDANSETRON HYDROCHLORIDEMYLAN LABORATORIES LTD2008-04-23ANDA078257_001Ondansetron Prefilled Syringe
32ANDA078287ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREECLARIS PHARMASERVICES2013-02-22ANDA078287_001Ondansetron Prefilled Syringe
33ANDA078288ONDANSETRON HYDROCHLORIDECLARIS PHARMASERVICES2013-02-22ANDA078288_001Ondansetron Prefilled Syringe
34ANDA078945ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEEMCURE PHARMACEUTICALS LTD2013-01-03ANDA078945_001Ondansetron Prefilled Syringe
35ANDA079032ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREELUITPOLD PHARMACEUTICALS INC2008-11-18ANDA079032_001Ondansetron Prefilled Syringe
36ANDA079039ONDANSETRON HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC2008-11-18ANDA079039_001Ondansetron Prefilled Syringe
37ANDA079224ONDANSETRON HYDROCHLORIDEGLAND PHARMA LTD2009-09-25ANDA079224_001Ondansetron Prefilled Syringe
38ANDA090116ONDANSETRON HYDROCHLORIDETrueLANNETT HOLDINGS INC2010-04-14ANDA090116_001Ondansetron Prefilled Syringe
39ANDA090424ONDANSETRON HYDROCHLORIDEEMCURE PHARMACEUTICALS LTD2010-04-16ANDA090424_001Ondansetron Prefilled Syringe
40ANDA090648ONDANSETRON HYDROCHLORIDEGLAND PHARMA LTD2012-06-15ANDA090648_001Ondansetron Prefilled Syringe
41ANDA090883ONDANSETRON HYDROCHLORIDELANNETT HOLDINGS INC2010-08-05ANDA090883_001Ondansetron Prefilled Syringe
42ANDA202253ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEBD RX INC2013-07-19ANDA202253_001Ondansetron Prefilled Syringe
43ANDA202599ONDANSETRON HYDROCHLORIDEAUROBINDO PHARMA LTD2012-12-21ANDA202599_001Ondansetron Prefilled Syringe
44ANDA202600ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEAUROBINDO PHARMA LTD2012-12-21ANDA202600_001Ondansetron Prefilled Syringe
45ANDA203711ONDANSETRON HYDROCHLORIDEQILU PHARMACEUTICAL CO LTD2014-09-08ANDA203711_001Ondansetron Prefilled Syringe
46ANDA206846ONDANSETRON HYDROCHLORIDEACCORD HEALTHCARE INC2015-07-13ANDA206846_001Ondansetron Prefilled Syringe
47NDA020007ZOFRANNOVARTIS PHARMACEUTICALS CORP1991-01-04NDA020007_001, NDA020007_003Ondansetron Prefilled Syringe
48NDA020403ZOFRAN AND DEXTROSE IN PLASTIC CONTAINERTrueGLAXOSMITHKLINE1995-01-31NDA020403_001Ondansetron Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076695_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalse2006-12-26ONDANSETRON HYDROCHLORIDE
2ANDA076696_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalse2006-12-26ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
3ANDA076759_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-11-22ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
4ANDA076780_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
5ANDA076781_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE
6ANDA076876_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-11-22ONDANSETRON HYDROCHLORIDE
7ANDA076967_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE
8ANDA076972_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
9ANDA076974_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE
10ANDA076978_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 0.64MG BASE/ML)INJECTIONFalse2007-02-26ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
11ANDA077011_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
12ANDA077172_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE
13ANDA077173_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
14ANDA077343_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalse2006-12-26ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
15ANDA077365_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE
16ANDA077368_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalse2006-12-26ONDANSETRON HYDROCHLORIDE
17ANDA077387_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalse2006-12-26ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
18ANDA077430_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2007-06-27ONDANSETRON HYDROCHLORIDE
19ANDA077473_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE
20ANDA077541_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
21ANDA077544_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalse2006-12-26ONDANSETRON HYDROCHLORIDE
22ANDA077548_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
23ANDA077551_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2007-06-27ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
24ANDA077577_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE
25ANDA077582_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalse2006-12-26ONDANSETRON HYDROCHLORIDE
26ANDA077716_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2006-12-26ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
27ANDA077840_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2007-01-19ONDANSETRON HYDROCHLORIDE
28ANDA078014_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalse2008-03-21ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
29ANDA078180_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalse2007-03-26ONDANSETRON HYDROCHLORIDE
30ANDA078244_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2008-04-23ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
31ANDA078257_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2008-04-23ONDANSETRON HYDROCHLORIDE
32ANDA078287_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2013-02-22ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
33ANDA078288_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2013-02-22ONDANSETRON HYDROCHLORIDE
34ANDA078945_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2013-01-03ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
35ANDA079032_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2008-11-18ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
36ANDA079039_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2008-11-18ONDANSETRON HYDROCHLORIDE
37ANDA079224_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2009-09-25ONDANSETRON HYDROCHLORIDE
38ANDA090116_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalse2010-04-14ONDANSETRON HYDROCHLORIDE
39ANDA090424_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2010-04-16ONDANSETRON HYDROCHLORIDE
40ANDA090648_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2012-06-15ONDANSETRON HYDROCHLORIDE
41ANDA090883_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2010-08-05ONDANSETRON HYDROCHLORIDE
42ANDA202253_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2013-07-19ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
43ANDA202599_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2012-12-21ONDANSETRON HYDROCHLORIDE
44ANDA202600_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2012-12-21ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
45ANDA203711_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2014-09-08ONDANSETRON HYDROCHLORIDE
46ANDA206846_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONFalseAP2015-07-13ONDANSETRON HYDROCHLORIDE
47NDA020007_001RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONTrueAP1991-01-04ZOFRAN
48NDA020007_003RXONDANSETRON HYDROCHLORIDE (EQ 2MG BASE/ML)INJECTIONTrueAP1993-12-10ZOFRAN
49NDA020403_001discontinuedONDANSETRON HYDROCHLORIDE (EQ 0.64MG BASE/ML)INJECTIONFalse1995-01-31ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b658a68-eb03-48dc-bf0b-bbc417f318fc (view SPL)These highlights do not include all the information needed to use Ondansetron Injection,USP safely and effectively. See full prescribing information for Ondansetron Injection,USP. Ondansetron Injection,USP(ondansetron hydrochloride) injection for intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE2013-05-082000691441
21b9c2d9f-62a8-4d26-a041-a598bc59e300 (view SPL)These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON. ONDANSETRON injection, USP for intravenous or intramuscular use Initial U.S. Approval: 2006prescriptionHuman PrescriptionCardinal HealthREPACK2015-06-153551546976
31cc94c7a-617c-4238-8248-e3fabc9612c7 (view SPL)These highlights do not include all the information needed to use ondansetron injection safely and effectively. See full prescribing information for ondansetron injection. ONDANSETRON INJECTION, USP for intravenousor intramuscular useInitial U.S. Approval: 1991prescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2015-02-216551500126
428e68c9e-b23d-4769-a880-17a95ff3fc5e (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. Initial U.S. Approval: 1991prescriptionHuman PrescriptionRemedyrepack Inc.2013-10-142521250744
52a09af01-3983-466f-8ed8-c849af848b56 (view SPL)Ondansetron in 5% Dextrose InjectionprescriptionHuman PrescriptionPfizer Labsanalysis, manufacture2010-04-051000690700
6302da2e0-3538-42fd-b712-45725a790fb0 (view SPL)ondansetron injection, USPprescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE2011-11-164000691340
735716914-ac73-43c0-9aa0-09c99211d941 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP.Ondansetron Injection, USP (ondansetron hydrochloride) injection for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionGland Pharma LimitedMANUFACTURE, PACK2015-02-182680830114
83784d6b8-ce99-4e96-aa73-b8f4c679f741 (view SPL)These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON injection, USP Ondansetron Injection, USP for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-10-272231550377
93efa5604-96c3-42a0-8e99-b3de4a66aa92 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP.Ondansetron Injection, USP (ondansetron hydrochloride) injection for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionGland Pharma LimitedMANUFACTURE, PACK2015-02-182680830113
1040fda14c-22f4-40ad-af64-5c637853b766 (view SPL)PRESCRIBING INFORMATIONONDANSETRON INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-051521250574
1142abd7f6-d3b0-4133-b9ca-258f699f7162 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for ONDANSETRON Injection, USP for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionSandoz Inc2014-11-0315007813010
1252a5f6b5-c35d-4966-9f87-38af278a4744 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. Initial U.S. Approval: 1991prescriptionHuman PrescriptionRemedyrepack Inc.2013-11-251521250744
135676fab0-b575-443a-8c67-656259d60264 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. Initial U.S. Approval: 1991prescriptionHuman PrescriptionRemedyrepack Inc.2013-11-251521250744
145bc2c91c-4192-4091-a677-ab24218c54dc (view SPL)PRESCRIBING INFORMATIONONDANSETRON INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-051521250574
155d18f175-b283-4316-bb44-287d0668e557 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP.Ondansetron Injection, USP for intravenous or intramuscular use Initial U.S. Approval: 1991prescriptionHuman PrescriptionRemedyrepack Inc.2014-10-201521250983
165e09e262-dadf-4ae0-825e-448ea8dac174 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection USP safely and effectively. See full prescribing information for Ondansetron Injection USP. ONDANSETRON Injection USP for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionQilu Pharmaceutical Co., Ltd.manufacture2014-10-156671840507
175eb3c741-f3af-4059-879a-732857488021 (view SPL)PRESCRIBING INFORMATIONONDANSETRON INJECTION USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-251521250574
1861758670-91ab-4422-8d9d-e8ca87eecae8 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. Ondansetron Injection, USP for intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionCardinal HealthREPACK2015-04-274551542877
19693ba38b-4cbe-4a6a-9c80-b9d2f554edce (view SPL)Ondansetron in Dextrose InjectionprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2010-02-022001439771
206a11f61b-2318-4382-2b91-4366e4bb53fa (view SPL)These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON. ONDANSETRON injection, USP for intravenous or intramuscular use Initial U.S. Approval: 2006prescriptionHuman PrescriptionHospira, Inc.2015-05-1415004094755, 004094759
216e76d0ef-93ca-4be9-8384-65656fe8bd47 (view SPL)These highlights do not include all the information needed to use ONDANSETRON injection, USP safely and effectively. See full prescribing information for ONDANSETRON injection, USP. ONDANSETRON injection, USP for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-055627560181, 627560182
226fe526f8-4e2b-4a74-b31f-306038d5e6c0 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection USP safely and effectively. See full prescribing information for Ondansetron Injection USP. ONDANSETRON Injection USP for intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionRemedyrepack Inc.2014-01-091521250809
23729d865f-d84a-495e-9456-4bceebb6e03f (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. Ondansetron Injection, USP for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionClaris Lifesciences Inc.2015-07-018360000012, 360000013
24758b42d4-811e-4e30-823e-bcfd85800065 (view SPL)These highlights do not include all the information needed to use ondansetron injection safely and effectively. See full prescribing information for ondansetron injection. ONDANSETRON INJECTION, USP for intravenousor intramuscular useInitial U.S. Approval: 1991prescriptionHuman PrescriptionCardinal HealthREPACK2015-08-133551548329
2576237ed8-cbee-4371-a1b7-623a714fed11 (view SPL)These highlights do not include all the information needed to use ondansetron injection safely and effectively. See full prescribing information for ondansetron injection. ONDANSETRON INJECTION, USP for intravenousor intramuscular useInitial U.S. Approval: 1991prescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-235551500125
267a6b44e7-afe0-480e-b84a-425d4295e123 (view SPL)These highlights do not include all the information needed to use Ondansetron safely and effectively. See full prescribing information for Ondansetron. Ondansetron (ondansetron hydrochloride) Injection, USP for intravenous use Initial U.S. Approval: 2006prescriptionHuman PrescriptionRemedyrepack Inc.2013-09-271521250334
278cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. ONDANSETRON injection, USP for intravenous or intramuscular useInitial U.S. Approval: 1991prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE, PACK2015-11-091231550548, 231550550
288e295c24-75d9-4728-86f8-a6375425f923 (view SPL)These highlights do not include all the information needed to use Ondansetron safely and effectively. See full prescribing information for Ondansetron. Ondansetron (ondansetron hydrochloride) Injection, USP for intravenous use Initial U.S. Approval: 2006prescriptionHuman PrescriptionRemedyrepack Inc.2013-11-251521250334
298f09046c-06a7-4141-8e48-d720e46a68b0 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection,USP safely and effectively. See full prescribing information for Ondansetron Injection,USP. Ondansetron Injection,USP(ondansetron hydrochloride) injection for intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE2013-05-083000691441
3097713356-f42b-4a67-95f6-561afa68c0c2 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. Ondansetron Injection, USP for intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2014-10-1711006416080
31993c5307-8054-4b2d-a013-6a70ebe77b5c (view SPL)These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON. ONDANSETRON injection, USP for intravenous or intramuscular use Initial U.S. Approval: 2006prescriptionHuman PrescriptionRemedyrepack Inc.2015-10-191617860435
32a194b8f8-163c-4e48-bc8b-871391010bab (view SPL)PRESCRIBING INFORMATION ONDANSETRON INJECTION USPprescriptionHuman PrescriptionWockhardt Usa Llc.manufacture2011-11-291646790726, 646790727
33a28ed7cd-2c67-4953-a6ca-3dc276c2cfff (view SPL)These highlights do not include all the information needed to use ondansetron injection safely and effectively. See full prescribing information for ondansetron injection.ONDANSETRON INJECTION, USP for intravenousor intramuscular useInitial U.S. Approval: 1991prescriptionHuman PrescriptionRemedyrepack Inc.2014-02-131521250834
34a360d43c-bed8-4f41-ab36-e2aa77dfbff2 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-08-151548685888
35b1089917-f63a-4031-a43a-e8c0b87c2849 (view SPL)These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON. ONDANSETRON injection, USP for intravenous or intramuscular use Initial U.S. Approval: 2006prescriptionHuman PrescriptionCardinal HealthREPACK2015-07-083551544731
36b746d4db-43e6-4219-9e6b-f53e59581305 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. ONDANSETRON injection, USP for intravenous or intramuscular useInitial U.S. Approval: 1991prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE, PACK2015-11-091231550547, 231550549
37ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP.Ondansetron Injection, USP (ondansetron hydrochloride) injection for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionSagent Pharmaceuticals2014-10-155250210777, 250210782
38bb4bc810-db26-471b-9ce7-6e2fb3018af0 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP ONDANSETRON Injection, USP for intravenous or intramuscular use. Initial U.S. Approval: 1991prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-03-2511001439890, 001439891
39be5930d2-0008-4e61-9715-684c29a9c613 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. ONDANSETRONInjection, USP for intravenous or intramuscularuse Initial U.S. Approval: 1991prescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-02-0920005271726
40bf5cbf1b-af47-419e-bc32-6d6b94a785b5 (view SPL)PRESCRIBING INFORMATION ONDANSETRON INJECTION USPprescriptionHuman PrescriptionWockhardt Limitedmanufacture2011-11-291556480726, 556480727
41c29ca6df-621d-44b6-98fc-b48666573366 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. Ondansetron Injection, USP for intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2014-10-0311006416078, 006416079
42c851ac17-0068-4320-94d4-fd955a26e1ac (view SPL)ondansetron injection, USPprescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE2011-11-161000691340
43cc6b5e2c-ae2a-4ec1-aa10-f8c85b3b3030 (view SPL)These highlights do not include all the information needed to use Ondansetron safely and effectively. See full prescribing information for Ondansetron. Ondansetron (ondansetron hydrochloride) Injection, USP for intravenous use Initial U.S. Approval: 2006prescriptionHuman PrescriptionRemedyrepack Inc.2013-11-251521250334
44d0360f27-1ca3-4995-b277-28091ac388fc (view SPL)These highlights do not include all the information needed to use Ondansetron Injection USP safely and effectively. See full prescribing information for Ondansetron Injection USP. ONDANSETRON injection USP for intravenous or intramuscular useInitial U.S. Approval: 1991prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-04-1011007037221
45d337b07d-5d72-428d-ac31-d8afbfd3b44b (view SPL)Ondansetron Injection, USPRx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2011-06-061551542872, 551542873
46d787900f-f617-478d-a65b-eef170e929f9 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection USP safely and effectively. See full prescribing information for Ondansetron Injection USP. ONDANSETRON injection USP for intravenous and intramuscular useInitial U.S. Approval: 1991prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-04-1011007037226
47d89ebc98-933a-4fa7-9ac7-6046b6dddd13 (view SPL)These highlights do not include all the information needed to use Ondansetron safely and effectively. See full prescribing information for Ondansetron. Ondansetron (ondansetron hydrochloride) Injection, USP for intravenous use Initial U.S. Approval: 2006prescriptionHuman PrescriptionRemedyrepack Inc.2013-06-141521250334
48d931b294-8834-4c7f-ac05-9aeb078cd86e (view SPL)Ondansetron in 5% Dextrose InjectionprescriptionHuman PrescriptionClaris Lifesciences Inc.analysis, manufacture2011-12-225360000014
49d9a71b42-ddfc-49d5-7280-0fc0041dba41 (view SPL)These highlights do not include all the information needed to use ZOFRAN safely and effectively. See full prescribing information for ZOFRAN. ZOFRAN (ondansetron hydrochloride) injection for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionGlaxosmithkline Llc2014-09-3015001730442
50dc3dc0e4-b7da-4da4-afa6-d57e4ee42339 (view SPL)Ondansetron Injection USPprescriptionHuman PrescriptionThe Medicines CompanyMANUFACTURE2013-03-201652930373, 652930374
51e0050959-c14c-41b6-9a92-fadc5f6feff3 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. Ondansetron Injection, USP for intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-11-267633230373, 633230374
52e8b042ef-b5ef-47c0-adea-b82a094fee0c (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP.Ondansetron Injection, USP for intravenous or intramuscular use Initial U.S. Approval: 1991prescriptionHuman PrescriptionRemedyrepack Inc.2014-07-071521250983
53ee1f115f-c8f8-4526-b827-c8e48aeb5050 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. Ondansetron Injection, USP for intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionCardinal HealthREPACK2015-07-14188557104551542876
54f1003333-104c-44bd-9c60-56f22ee4f955 (view SPL)These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON injection, USPOndansetron Injection, USP for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-10-272231550378
55f1395040-4d33-4db3-aeb7-6aeda172b77f (view SPL)These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON injection, USP Ondansetron Injection, USP for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2014-10-2716231550168
56f21c82e6-8660-4e00-a1fa-7db803868a14 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. Initial U.S. Approval: 1991prescriptionHuman PrescriptionRemedyrepack Inc.2013-12-171521250744
57f927b041-1d05-478c-ac26-066d9c782c5e (view SPL)Ondansetron Injection, USPRx onlyprescriptionHuman PrescriptionBaxter Healthcare CorporationMANUFACTURE2010-11-022100190905, 100190906
58fa8c2931-35a7-4b4b-8be2-eda701b51079 (view SPL)These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. See full prescribing information for Ondansetron Injection, USP. ONDANSETRON injection, USP (ondansetron hydrochloride) injection for intravenous use Initial U.S. Approval: 1991prescriptionHuman PrescriptionMylan Institutional Llc2014-10-152674570440, 674570441
59ff42153c-9c0e-40e0-b21c-376010548dcc (view SPL)These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON injection, USPOndansetron Injection, USP for intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-10-277231550196

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