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ACTIVE SUBSTANCE / INN

DIENOGEST

Brand name(s): NATAZIA, ESTRADIOL VALERATE AND DIENOGEST, ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST
FDA LISTED
PRESCRIPTION
NONE (TENTATIVE APPROVAL)
ANDA202349
NDA022252
ACTIVE SUBSTANCE
Dienogest
REGULATORS
FDA
SPONSORS / MAH
WATSON LABS INC, DR REDDYS LABS SA, BAYER HLTHCARE
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NATAZIANDA022252BAYER HLTHCAREPrescription
ESTRADIOL VALERATE AND DIENOGESTANDA202349WATSON LABS INCPrescription
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGESTANDA202999DR REDDYS LABS SANone (Tentative Approval)

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