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ACTIVE SUBSTANCE / INN

SPIRONOLACTONE

Brand name(s): SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE, ALDACTONE, ALDACTAZIDE, SPIRONOLACTONE, SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, CAROSPIR, Qaialdo
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA087398
ANDA040424
ACTIVE SUBSTANCE
Spironolactone
REGULATORS
FDA · EMA
SPONSORS / MAH
WATSON LABS, CMP DEV LLC, IVAX PHARMS
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SPIRONOLACTONEANDA040424MYLANPrescription
SPIRONOLACTONEANDA086898WATSON LABSDiscontinued
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEANDA087398WATSON LABSDiscontinued
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEANDA089534SUN PHARM INDUSTRIESPrescription
ALDACTAZIDENDA012616PFIZERDiscontinued
ALDACTAZIDENDA012616PFIZERPrescription
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDEANDA087004IVAX PHARMSDiscontinued
ALDACTONENDA012151PFIZERPrescription
CAROSPIRNDA209478CMP DEV LLCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
QaialdoLipomed GmbHAuthorised26/05/2023Edema;Heart Failure;Liver Cirrhosis;Ascites;Nephrotic Syndrome;Hyperaldosteronis…

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