ACTIVE SUBSTANCE / INN

DRONEDARONE HYDROCHLORIDE

Brand name(s): DRONEDARONE HYDROCHLORIDE, MULTAQ
FDA LISTED
PRESCRIPTION
NONE (TENTATIVE APPROVAL)
ANDA205682
ANDA205904
ACTIVE SUBSTANCE
Dronedarone Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
WATSON LABS INC, LUPIN, SANOFI AVENTIS US
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DRONEDARONE HYDROCHLORIDEANDA205682WATSON LABS INCNone (Tentative Approval)
DRONEDARONE HYDROCHLORIDEANDA205904LUPINPrescription
MULTAQNDA022425SANOFI AVENTIS USPrescription

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