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ACTIVE SUBSTANCE / INN

SEVELAMER CARBONATE

Brand name(s): SEVELAMER CARBONATE, Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva), RENVELA, Renvela
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA206234
ANDA203860
ACTIVE SUBSTANCE
Sevelamer Carbonate
REGULATORS
FDA · EMA
SPONSORS / MAH
Sanofi Winthrop Industrie, INVAGEN PHARMS, GENZYME
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SEVELAMER CARBONATEANDA203860INVAGEN PHARMSPrescription
SEVELAMER CARBONATEANDA206234INVAGEN PHARMSDiscontinued
RENVELANDA022318GENZYMEPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RenvelaSanofi Winthrop IndustrieAuthorised09/06/2009Hyperphosphatemia;Renal Dialysis
Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)Sanofi Winthrop IndustrieAuthorised15/01/2015Hyperphosphatemia;Renal Dialysis

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