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FDA NDA · NDA021048

ESTRADIOL

Sponsor: ORTHO MCNEIL PHARM

APPLICATION
NDA021048
TYPE
NDA
ORIGINAL APPROVAL
1999-09-20
LATEST ACTION
1999-09-20
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Discontinued

Products

ESTRADIOLDiscontinued
ESTRADIOL 0.075MG/24HR · SYSTEM · TRANSDERMAL
ESTRADIOLDiscontinued
ESTRADIOL 0.1MG/24HR · SYSTEM · TRANSDERMAL
ESTRADIOLDiscontinued
ESTRADIOL 0.05MG/24HR · SYSTEM · TRANSDERMAL

Approval history

1999-09-20Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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