ACTIVE SUBSTANCE / INN

LABETALOL HYDROCHLORIDE

Brand name(s): TRANDATE HCT, LABETALOL HYDROCHLORIDE IN DEXTROSE, LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE, NORMODYNE, TRANDATE, NORMOZIDE, LABETALOL HYDROCHLORIDE
FDA LISTED
PRESCRIPTION
DISCONTINUED
ANDA211325
NDA019174
ACTIVE SUBSTANCE
Labetalol Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
SEBELA IRELAND LTD, HOSPIRA, CADILA PHARMS LTD
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LABETALOL HYDROCHLORIDEANDA211325CADILA PHARMS LTDPrescription
NORMODYNENDA018687SCHERINGDiscontinued
LABETALOL HYDROCHLORIDEANDA075242HOSPIRADiscontinued
TRANDATE HCTNDA019174GLAXOSMITHKLINEDiscontinued
TRANDATENDA019425SEBELA IRELAND LTDDiscontinued
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDENDA213330HIKMAPrescription
LABETALOL HYDROCHLORIDE IN DEXTROSENDA213330HIKMAPrescription
NORMOZIDENDA019046SCHERINGDiscontinued

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