vinorelbine Injectable Solution

Brand(s)
Navelbine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pierre Fabre Pharmaceuticals, Inc. (2014-05-12)
Oldest Current Product
2003-03-01
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\VINORELBINE
FDAOB
INJECTION\INJECTION\VINORELBINE TARTRATE\rdfq
INJECTION\INJECTION\VINORELBINE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\VINORELBINE TARTRATE
INTRAVENOUS\INJECTION, SOLUTION\VINORELBINE
INTRAVENOUS\INJECTION, SOLUTION\VINORELBINE TARTRATE
INTRAVENOUS\INJECTION\VINORELBINE TARTRATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\VINORELBINE
INTRAVENOUS\INJECTION, SOLUTION\VINORELBINE
INTRAVENOUS\INJECTION\VINORELBINE

product(s) by strength(s)

vinorelbine 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1643700532NavelbineNDAPierre Fabre Pharmaceuticals, Inc.2005-11-15VINORELBINE TARTRATEINTRAVENOUSINJECTIONNDA0203886d47c96a-7fdc-48ac-9250-41c5d3ecf8db

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690099ANDAPfizer Labs2012-09-01VINORELBINE TARTRATEINTRAVENOUSINJECTION, SOLUTIONANDA200148deac0e4c-91fd-40ac-b478-0236291af3c0
2000690205ANDAPfizer Labs2012-09-01VINORELBINE TARTRATEINTRAVENOUSINJECTION, SOLUTIONANDA200148831c2287-e7d1-41ff-90ed-1ddd38350590
3007034182ANDATeva Parenteral Medicines, Inc2003-03-01VINORELBINE TARTRATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA076028fa49b48c-49ce-4a95-8d3f-70ca304926fb
4007034183ANDATeva Parenteral Medicines, Inc2003-03-01VINORELBINE TARTRATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA076028fa49b48c-49ce-4a95-8d3f-70ca304926fb
5250210204ANDASagent Pharmaceuticals2014-09-15VINORELBINE TARTRATEINTRAVENOUSINJECTION, SOLUTIONANDA09110610a70995-e04d-4044-b1dc-c9aa27460397
6459630607ANDAActavis Inc.2009-09-14VINORELBINEINTRAVENOUSINJECTION, SOLUTIONANDA078011dd3dcc9a-e40c-4677-9ee6-f318e7c7d835
7617030341ANDAHospira Worldwide, Inc.2005-06-02VINORELBINE TARTRATEINTRAVENOUSINJECTION, SOLUTIONANDA07682706eeaab8-a00d-4b41-b46b-40163f09ecb8
8674570431ANDAMylan Institutional Llc2012-09-01VINORELBINE TARTRATEINTRAVENOUSINJECTION, SOLUTIONANDA2001486a4d9c3b-1db8-4090-810c-3794b3ca59a4
9674570481ANDAMylan Institutional Llc2012-09-01VINORELBINE TARTRATEINTRAVENOUSINJECTION, SOLUTIONANDA200148a37eb006-7c53-4f86-846c-955c5241b5f6
10674570482ANDAMylan Institutional Llc2012-09-01VINORELBINE TARTRATEINTRAVENOUSINJECTION, SOLUTIONANDA200148a37eb006-7c53-4f86-846c-955c5241b5f6

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1667580045ANDASandoz Inc2008-02-13VINORELBINE TARTRATEINTRAVENOUSINJECTION, SOLUTIONANDA07840817badb0d-de35-40f4-8a9d-f03397de62ab

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075992VINORELBINE TARTRATEEUROHEALTH INTERNATIONAL SARL2003-06-10ANDA075992_001
2ANDA076028VINORELBINE TARTRATETEVA PHARMACEUTICALS USA2003-02-03ANDA076028_001
3ANDA076461VINORELBINE TARTRATEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2003-12-11ANDA076461_001
4ANDA076827VINORELBINE TARTRATEHOSPIRA INC2005-06-02ANDA076827_001
5ANDA076849VINORELBINE TARTRATEFRESENIUS KABI USA LLC2005-04-18ANDA076849_001
6ANDA078011VINORELBINE TARTRATEACTAVIS TOTOWA LLC2009-07-22ANDA078011_001
7ANDA078408VINORELBINE TARTRATETrueEBEWE PHARMA GES MBH NFG KG2008-02-13ANDA078408_001
8ANDA091106VINORELBINE TARTRATEJIANGSU HANSOH PHARMACEUTICAL CO LTD2012-09-26ANDA091106_001
9ANDA200148VINORELBINEMYLAN LABORATORIES LTD2012-08-31ANDA200148_001
10ANDA202017VINORELBINE TARTRATEDR REDDYS LABORATORIES LTD2013-09-12ANDA202017_001
11NDA020388NAVELBINEPIERRE FABRE MEDICAMENT1994-12-23NDA020388_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075992_001RXVINORELBINE TARTRATE (EQ 10MG BASE/ML)INJECTIONFalseAP2003-06-10VINORELBINE TARTRATE
2ANDA076028_001RXVINORELBINE TARTRATE (EQ 10MG BASE/ML)INJECTIONFalseAP2003-02-03VINORELBINE TARTRATE
3ANDA076461_001RXVINORELBINE TARTRATE (EQ 10MG BASE/ML)INJECTIONFalseAP2003-12-11VINORELBINE TARTRATE
4ANDA076827_001RXVINORELBINE TARTRATE (EQ 10MG BASE/ML)INJECTIONFalseAP2005-06-02VINORELBINE TARTRATE
5ANDA076849_001RXVINORELBINE TARTRATE (EQ 10MG BASE/ML)INJECTIONFalseAP2005-04-18VINORELBINE TARTRATE
6ANDA078011_001RXVINORELBINE TARTRATE (EQ 10MG BASE/ML)INJECTIONFalseAP2009-07-22VINORELBINE TARTRATE
7ANDA078408_001discontinuedVINORELBINE TARTRATE (EQ 10MG BASE/ML)INJECTIONFalse2008-02-13VINORELBINE TARTRATE
8ANDA091106_001RXVINORELBINE TARTRATE (EQ 10MG BASE/ML)INJECTIONFalseAP2012-09-26VINORELBINE TARTRATE
9ANDA200148_001RXVINORELBINE (EQ 10MG BASE/ML)INJECTIONFalseAP2012-08-31VINORELBINE
10ANDA202017_001RXVINORELBINE TARTRATE (EQ 10MG BASE/ML)INJECTIONFalseAP2013-09-12VINORELBINE TARTRATE
11NDA020388_001RXVINORELBINE TARTRATE (EQ 10MG BASE/ML)INJECTIONTrueAP1994-12-23NAVELBINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
106eeaab8-a00d-4b41-b46b-40163f09ecb8 (view SPL)These highlights do not include all the information needed to use VINORELBINE TARTRATE INJECTION safely and effectively. See full prescribing information for VINORELBINE TARTRATE INJECTION.VINORELBINE TARTRATE INJECTION for intravenous useInitial U.S. Approval: 2005prescriptionHuman PrescriptionHospira Worldwide, Inc.2015-03-1612617030341
210a70995-e04d-4044-b1dc-c9aa27460397 (view SPL)These highlights do not include all the information needed to use Vinorelbine Injection, USP safely and effectively. See full prescribing information for Vinorelbine Injection, USP.Vinorelbine Injection, USP, for intravenous useInitial U.S. Approval: 1994prescriptionHuman PrescriptionSagent Pharmaceuticals2014-05-144250210204
317badb0d-de35-40f4-8a9d-f03397de62ab (view SPL)Vinorelbine Injection USPprescriptionHuman PrescriptionSandoz Inc2011-09-195667580045
46a4d9c3b-1db8-4090-810c-3794b3ca59a4 (view SPL)These highlights do not include all the information needed to use Vinorelbine Injection, USP safely and effectively. See full prescribing information for Vinorelbine Injection, USP.VINORELBINE Injection, USP for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionMylan Institutional Llc2014-05-292674570431
56d47c96a-7fdc-48ac-9250-41c5d3ecf8db (view SPL)These highlights do not include all the information needed to use NAVELBINE safely and effectively. See full prescribing information for NAVELBINE. NAVELBINE (vinorelbine tartrate) injection, for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionPierre Fabre Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-05-1213643700532
6831c2287-e7d1-41ff-90ed-1ddd38350590 (view SPL)Vinorelbine Injection USPprescriptionHuman PrescriptionPfizer Labs2013-03-081000690205
7a37eb006-7c53-4f86-846c-955c5241b5f6 (view SPL)These highlights do not include all the information needed to use Vinorelbine Injection, USP safely and effectively. See full prescribing information for Vinorelbine Injection, USP. VINORELBINE Injection, USP for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionMylan Institutional LlcANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-12-012674570481, 674570482
8dd3dcc9a-e40c-4677-9ee6-f318e7c7d835 (view SPL)These highlights do not include all the information needed to use vinorelbine injection safely and effectively. See full prescribing information for vinorelbine injection. VINORELBINE injection, USP, for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-05-2919459630607
9deac0e4c-91fd-40ac-b478-0236291af3c0 (view SPL)Vinorelbine Injection USPprescriptionHuman PrescriptionPfizer Labs2012-07-181000690099
10fa49b48c-49ce-4a95-8d3f-70ca304926fb (view SPL)These highlights do not include all the information needed to use vinorelbine injection USP safely and effectively. See full prescribing information for vinorelbine injection USP. VINORELBINE injection, for intravenous use Initial U.S. Approval: 1994prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-09-106007034182, 007034183

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