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FDA ANDA · ANDA020167

ESTRADIOL

Sponsor: MYLAN PHARMS INC

APPLICATION
ANDA020167
TYPE
ANDA
ORIGINAL APPROVAL
2014-12-19
LATEST ACTION
2014-12-19
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

ESTRADIOLPrescription
ESTRADIOL 0.1MG/DAY · SYSTEM · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.05MG/DAY · SYSTEM · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.025MG/DAY · SYSTEM · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.075MG/DAY · SYSTEM · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.0375MG/DAY · SYSTEM · TRANSDERMAL

Approval history

2014-12-19UNKNOWN · Original · unknownReviewAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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