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ACTIVE SUBSTANCE / INN

ONDANSETRON HYDROCHLORIDE

Brand name(s): ZOFRAN, ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE, ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER, ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
NDA020403
ANDA076974
ACTIVE SUBSTANCE
Ondansetron Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
WOCKHARDT BIO AG, HOSPIRA, SANDOZ
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ONDANSETRON HYDROCHLORIDEANDA076695HOSPIRADiscontinued
ONDANSETRON HYDROCHLORIDEANDA076974FRESENIUS KABI USAPrescription
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINERNDA020403GLAXOSMITHKLINEDiscontinued
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEANDA077716WOCKHARDT BIO AGPrescription
ZOFRANNDA020007SANDOZDiscontinued
ZOFRAN PRESERVATIVE FREENDA020007SANDOZDiscontinued
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEANDA078244ONESOURCE SPECIALTYDiscontinued
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINERANDA076978HOSPIRADiscontinued
ONDANSETRON HYDROCHLORIDEANDA077303CHARTWELL MOLECULESNone (Tentative Approval)

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