Ondansetron Prefilled Syringe

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-10-13)
Oldest Current Product
2007-01-19
License(s)
ANDA
RxNORM
PREFILLED SYRINGE\ONDANSETRON
FDAOB
INJECTION\INJECTION\ONDANSETRON HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\ONDANSETRON HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\ONDANSETRON HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\ONDANSETRON
INTRAVENOUS\INJECTION, SOLUTION\ONDANSETRON

product(s) by strength(s)

2 ml ondansetron 2 mg/ml prefilled syringe

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091120ANDAHospira, Inc.2007-01-19ONDANSETRON HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA077840b3c77207-e106-46e3-aa18-9f5f62d79dd6
2760450103ANDABd Rx Inc.2013-08-23ONDANSETRON HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA202253d89017aa-b8c3-4fd2-8e68-44e2cfd6f290

application(s)

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

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)
1b3c77207-e106-46e3-aa18-9f5f62d79dd6 (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 intravenous use Initial U.S. Approval: 2007prescriptionHuman PrescriptionHospira, Inc.2015-10-135004091120
2d89017aa-b8c3-4fd2-8e68-44e2cfd6f290 (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 intravenous useInitial U.S. Approval: 1991prescriptionHuman PrescriptionBd Rx Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-01-197760450103

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