ACTIVE SUBSTANCE / INN

SIMVASTATIN

Brand name(s): ZOCOR, FLOLIPID, JUVISYNC, SIMVASTATIN, VYTORIN, EZETIMIBE AND SIMVASTATIN
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA201890
ANDA077691
ACTIVE SUBSTANCE
Simvastatin
REGULATORS
FDA
SPONSORS / MAH
SALERNO PHARMS, TEVA PHARMS, SUN PHARM INDS LTD
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SIMVASTATINANDA076532TEVA PHARMSNone (Tentative Approval)
FLOLIPIDNDA206679SALERNO PHARMSPrescription
SIMVASTATINANDA076285SUN PHARM INDS LTDDiscontinued
SIMVASTATINANDA077691AUROBINDO PHARMAPrescription
EZETIMIBE AND SIMVASTATINANDA200082AUROBINDO PHARMA USAPrescription
EZETIMIBE AND SIMVASTATINANDA201890ANI PHARMSDiscontinued
JUVISYNCNDA202343MERCK SHARP DOHMEDiscontinued
ZOCORNDA019766ORGANONDiscontinued
ZOCORNDA019766ORGANONPrescription
VYTORINNDA021687ORGANONPrescription

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