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FDA ANDA · ANDA040628

ESTRADIOL VALERATE

Sponsor: FOSUN PHARMA

APPLICATION
ANDA040628
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-04
LATEST ACTION
2007-10-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ESTRADIOL VALERATEDiscontinued
ESTRADIOL VALERATE 20MG/ML · INJECTABLE · INJECTION
ESTRADIOL VALERATEDiscontinued
ESTRADIOL VALERATE 40MG/ML · INJECTABLE · INJECTION
ESTRADIOL VALERATEDiscontinued
ESTRADIOL VALERATE 10MG/ML · INJECTABLE · INJECTION

Approval history

2007-10-04OriginalAP
VIEW ON DRUGS@FDA ↗

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