Vincristine Injectable Solution

Brand(s)
Vincasar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira Worldwide, Inc. (2014-01-27)
Oldest Current Product
1988-04-19
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\VINCRISTINE
FDAOB
INJECTION\INJECTION\VINCRISTINE SULFATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\VINCRISTINE SULFATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\VINCRISTINE

product(s) by strength(s)

vincristine sulfate 1 mg/ml injectable solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007034402VincasarANDATeva Parenteral Medicines, Inc2000-05-01VINCRISTINE SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA07549301cee93f-3ab9-44fa-8c9a-dd5958fd2db9
2007034412VincasarANDATeva Parenteral Medicines, Inc2000-05-01VINCRISTINE SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA07549301cee93f-3ab9-44fa-8c9a-dd5958fd2db9
3617030309ANDAHospira Worldwide, Inc.1988-04-19VINCRISTINE SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA07148449596de6-ab18-49d1-9e5b-30968fc21c36

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070411VINCRISTINE SULFATETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-09-10ANDA070411_001
2ANDA070867VINCREXTrueBRISTOL MYERS SQUIBB1988-07-12ANDA070867_001
3ANDA070873VINCRISTINE SULFATETrueABIC LTD1987-02-19ANDA070873_001
4ANDA071426VINCASAR PFSTrueTEVA PARENTERAL MEDICINES INC1987-07-17ANDA071426_001
5ANDA071484VINCRISTINE SULFATE PFSHOSPIRA WORLDWIDE, INC1988-04-19ANDA071484_001
6ANDA071559VINCRISTINE SULFATETrueHOSPIRA INC1988-04-11ANDA071559_001
7ANDA071560VINCRISTINE SULFATETrueHOSPIRA INC1988-04-11ANDA071560_001
8ANDA071561VINCRISTINE SULFATETrueHOSPIRA INC1988-04-11ANDA071561_001
9ANDA075493VINCRISTINE SULFATE PFSTEVA PHARMACEUTICALS USA1999-09-01ANDA075493_001
10ANDA076296VINCRISTINE SULFATETrueFRESENIUS KABI USA LLC2002-12-20ANDA076296_001
11ANDA076401VINCRISTINE SULFATETrueFRESENIUS KABI USA LLC2003-10-28ANDA076401_001
12NDA014103ONCOVINTrueELI LILLY AND CONDA014103_001, NDA014103_002, NDA014103_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070411_001discontinuedVINCRISTINE SULFATE (1MG/ML)INJECTIONFalse1986-09-10VINCRISTINE SULFATE
2ANDA070867_001discontinuedVINCRISTINE SULFATE (5MG/VIAL)INJECTIONFalse1988-07-12VINCREX
3ANDA070873_001discontinuedVINCRISTINE SULFATE (1MG/ML)INJECTIONFalse1987-02-19VINCRISTINE SULFATE
4ANDA071426_001discontinuedVINCRISTINE SULFATE (1MG/ML)INJECTIONFalse1987-07-17VINCASAR PFS
5ANDA071484_001RXVINCRISTINE SULFATE (1MG/ML)INJECTIONTrueAP1988-04-19VINCRISTINE SULFATE PFS
6ANDA071559_001discontinuedVINCRISTINE SULFATE (1MG/VIAL)INJECTIONFalse1988-04-11VINCRISTINE SULFATE
7ANDA071560_001discontinuedVINCRISTINE SULFATE (2MG/VIAL)INJECTIONFalse1988-04-11VINCRISTINE SULFATE
8ANDA071561_001discontinuedVINCRISTINE SULFATE (5MG/VIAL)INJECTIONFalse1988-04-11VINCRISTINE SULFATE
9ANDA075493_001RXVINCRISTINE SULFATE (1MG/ML)INJECTIONFalseAP1999-09-01VINCRISTINE SULFATE PFS
10ANDA076296_001discontinuedVINCRISTINE SULFATE (1MG/ML)INJECTIONFalse2002-12-20VINCRISTINE SULFATE
11ANDA076401_001discontinuedVINCRISTINE SULFATE (1MG/ML)INJECTIONFalse2003-10-28VINCRISTINE SULFATE
12NDA014103_001discontinuedVINCRISTINE SULFATE (1MG/VIAL)INJECTIONFalseONCOVIN
13NDA014103_002discontinuedVINCRISTINE SULFATE (5MG/VIAL)INJECTIONFalseONCOVIN
14NDA014103_003discontinuedVINCRISTINE SULFATE (1MG/ML)INJECTIONFalse1984-03-07ONCOVIN

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
101cee93f-3ab9-44fa-8c9a-dd5958fd2db9 (view SPL)VINCASAR PFS (vinCRIStine sulfate injection USP)prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2014-10-228007034402, 007034412
249596de6-ab18-49d1-9e5b-30968fc21c36 (view SPL)VinCRIStine Sulfate Injection, USPprescriptionHuman PrescriptionHospira Worldwide, Inc.2014-01-2713617030309

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