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ACTIVE SUBSTANCE / INN

DROSPIRENONE

Brand name(s): NEXTSTELLIS, LORYNA, SAFYRAL, DROSPIRENONE, BEYAZ, YAZ, KEMEYA, LO-ZUMANDIMINE, DROSPIRENONE AND ETHINYL ESTRADIOL
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
NDA021873
NDA214154
ACTIVE SUBSTANCE
Drospirenone
REGULATORS
FDA
SPONSORS / MAH
LUPIN LTD, AUROBINDO PHARMA LTD, BARR
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DROSPIRENONE AND ETHINYL ESTRADIOLANDA201663LUPIN LTDPrescription
KEMEYAANDA202138SUN PHARMDiscontinued
YAZNDA021873BAYER HLTHCAREPrescription
SAFYRALNDA022574BAYER HLTHCAREPrescription
DROSPIRENONE AND ETHINYL ESTRADIOLANDA078515BARRDiscontinued
LORYNAANDA079221XIROMEDPrescription
DROSPIRENONEANDA216936LUPIN LTDNone (Tentative Approval)
LO-ZUMANDIMINEANDA209632AUROBINDO PHARMA LTDPrescription
NEXTSTELLISNDA214154MAYNE PHARMAPrescription
BEYAZNDA022532BAYER HLTHCAREPrescription

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