Mesna Injectable Solution

Brand(s)
Mesnex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2015-03-20)
Oldest Current Product
1988-12-30
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\MESNA
FDAOB
INTRAVENOUS\INJECTION\MESNA
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\MESNA
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\2-MERCAPTOETHANESULFONIC ACID
INTRAVENOUS\INJECTION, SOLUTION\2-MERCAPTOETHANESULFONIC ACID: MESNA

product(s) by strength(s)

mesna 100 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1100190953NDABaxter Healthcare Corporation1988-12-30MESNAINTRAVENOUSINJECTION, SOLUTIONNDA019884fe1683ef-0569-411e-8188-0499884632ad

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007034805ANDATeva Parenteral Medicines, Inc2002-05-01MESNAINTRAVENOUSINJECTION, SOLUTIONANDA07576426a12d79-fd1b-4e49-bbf0-0d55784379b8
2250210201ANDASagent Pharmaceuticals2010-12-01, 2013-04-30MESNAINTRAVENOUSINJECTION, SOLUTIONANDA0909132a2a526f-636b-7920-4261-6c626f612a2a, 3e022f7c-87dd-41d1-a518-730e16722b09, 616c111c-0cc5-4df2-be67-01ee005cf527
3633230733ANDAApp Pharmaceuticals, Llc2001-09-05MESNAINTRAVENOUSINJECTION, SOLUTIONANDA075811ef161ede-0451-43c8-b0e5-cb108b138e38
4674570148ANDAMylan Institutional Llc2012-04-03MESNAINTRAVENOUSINJECTION, SOLUTIONANDA07648871236841-707e-45d0-ac4b-7c1423be531b
5761260075ANDAAgila Specialties Private Limited2014-07-19MESNAINTRAVENOUSINJECTION, SOLUTIONANDA2033648c79a07d-32cc-4fe7-9a74-152c169f1c4f

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA075739MESNAEUROHEALTH INTERNATIONAL SARL2004-01-09ANDA075739_001
2ANDA075764MESNATEVA PHARMACEUTICALS USA2001-04-27ANDA075764_001
3ANDA075811MESNAFRESENIUS KABI USA LLC2001-04-26ANDA075811_001
4ANDA076488MESNAMYLAN INSTITUTIONAL LLC2012-03-08ANDA076488_001
5ANDA090913MESNASAGENT PHARMACEUTICALS INC2010-04-13ANDA090913_001
6ANDA203364MESNAMYLAN LABORATORIES LTD2014-07-18ANDA203364_001
7NDA019884MESNEXBAXTER HEALTHCARE CORP1988-12-30NDA019884_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075739_001RXMESNA (100MG/ML)INTRAVENOUSINJECTIONFalseAP2004-01-09MESNA
2ANDA075764_001RXMESNA (100MG/ML)INTRAVENOUSINJECTIONFalseAP2001-04-27MESNA
3ANDA075811_001RXMESNA (100MG/ML)INTRAVENOUSINJECTIONFalseAP2001-04-26MESNA
4ANDA076488_001RXMESNA (100MG/ML)INTRAVENOUSINJECTIONFalseAP2012-03-08MESNA
5ANDA090913_001RXMESNA (100MG/ML)INTRAVENOUSINJECTIONFalseAP2010-04-13MESNA
6ANDA203364_001RXMESNA (100MG/ML)INTRAVENOUSINJECTIONFalseAP2014-07-18MESNA
7NDA019884_001RXMESNA (100MG/ML)INTRAVENOUSINJECTIONTrueAP1988-12-30MESNEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
126a12d79-fd1b-4e49-bbf0-0d55784379b8 (view SPL)These highlights do not include all the information needed to use mesna injection safely and effectively. See full prescribing information formesna injection. MESNA injection, for intravenous use Initial U.S. Approval: 1988prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-09-175007034805
22a2a526f-636b-7920-4261-6c626f612a2a (view SPL)These highlights do not include all the information needed to use MESNA INJECTION safely and effectively. See full prescribing information for MESNA INJECTION.Mesna Injection, for intravenous useInitial U.S. Approval: 1988prescriptionHuman PrescriptionSagent Pharmaceuticals2014-04-294250210201
33e022f7c-87dd-41d1-a518-730e16722b09 (view SPL)These highlights do not include all the information needed to use MESNA INJECTION safely and effectively. See full prescribing information for MESNA INJECTION.Mesna Injection, for intravenous useInitial U.S. Approval: 1988prescriptionHuman PrescriptionSagent Pharmaceuticals2014-04-303250210201
449fdfbc3-69f8-4706-9d11-bf60e4e7811b (view SPL)These highlights do not include all the information needed to use MESNEX safely and effectively. See full prescribing information for MESNEX. MESNEX (mesna) injection, for intravenous useMESNEX (mesna) tablets, for oral useInitial U.S. Approval: 1988prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, STERILIZE2014-03-177003381305
5616c111c-0cc5-4df2-be67-01ee005cf527 (view SPL)These highlights do not include all the information needed to use MESNA INJECTION safely and effectively. See full prescribing information for MESNA INJECTION.Mesna Injection, for intravenous useInitial U.S. Approval: 1988prescriptionHuman PrescriptionSagent Pharmaceuticals2014-04-302250210201
671236841-707e-45d0-ac4b-7c1423be531b (view SPL)These highlights do not include all the information needed to use mesna injection safely and effectively. See full prescribing information for mesna injection. MESNA injection, for intravenous use Initial U.S. Approval: 1988prescriptionHuman PrescriptionMylan Institutional Llc2014-03-313674570148
78c79a07d-32cc-4fe7-9a74-152c169f1c4f (view SPL)These highlights do not include all the information needed to use Mesna Injection safely and effectively. See full prescribing information for Mesna Injection. Mesna Injection for Intravenous Use Initial U.S. Approval: 1988prescriptionHuman PrescriptionAgila Specialties Private LimitedAnalysis, Manufacture, Pack, Sterilize2014-07-222761260075
8ef161ede-0451-43c8-b0e5-cb108b138e38 (view SPL)These highlights do not include all the information needed to use Mesna Injection safely and effectively. See full prescribing information for Mesna Injection.Mesna Injection, for intravenous useInitial U.S. Approval: 1988prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-10-212633230733
9fe1683ef-0569-411e-8188-0499884632ad (view SPL)These highlights do not include all the information needed to use mesna safely and effectively. See full prescribing information for mesna. Mesna injection, for intravenous use MESNEX (mesna) tablets, for oral use Initial U.S. Approval: 1988prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, STERILIZE2015-03-204100190953

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