Varicella-Zoster Virus Vaccine Live (Oka-Merck) strain Injection

Brand(s)
Varivax, Zostavax
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Merck Sharp & Dohme Corp. (2015-06-02)
Oldest Current Product
1995-03-17
License(s)
BLA
RxNORM
INJECTION\VARICELLA-ZOSTER VIRUS VACCINE LIVE (OKA-MERCK) STRAIN
SPL Active
SUBCUTANEOUS\INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION\VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN
SPL Moiety
SUBCUTANEOUS\INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION\VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN

product(s) by strength(s)

0.5 ml varicella-zoster virus vaccine live (oka-merck) strain 2700 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000064826VarivaxBLAMerck Sharp & Dohme Corp.1995-03-17VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGENSUBCUTANEOUSINJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION103552524cf052-e90e-4595-af0a-608edbe9bd31

0.65 ml varicella-zoster virus vaccine live (oka-merck) strain 29800 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000064963ZostavaxBLAMerck Sharp & Dohme Corp.2006-05-25VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGENSUBCUTANEOUSINJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION12512330a0464e-e012-4c16-bc05-88f07e412203

application(s)

#idtitleapprovedfda division
1103552Varicella Virus Vaccine LiveVarivax Application1995-03-17CBER
2125123Zoster Vaccine LiveZostavax Application2006-05-25CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
130a0464e-e012-4c16-bc05-88f07e412203 (view SPL)These highlights do not include all the information needed to use ZOSTAVAX safely and effectively. See full prescribing information for ZOSTAVAX. ZOSTAVAX (Zoster Vaccine Live) Suspension for subcutaneous injectionInitial U.S. Approval: 2006otherVaccineMerck Sharp & Dohme Corp.2015-06-0228000064963
2524cf052-e90e-4595-af0a-608edbe9bd31 (view SPL)These highlights do not include all the information needed to use VARIVAX safely and effectively. See full prescribing information for VARIVAX. VARIVAXVaricella Virus Vaccine LiveSuspension for subcutaneous injectionInitial U.S. Approval: 1995otherVaccineMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2014-10-0823000064826, 000064827

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