← FDA DRUG APPROVALS

FDA NDA · NDA021633

FEMTRACE

Sponsor: APIL

APPLICATION
NDA021633
TYPE
NDA
ORIGINAL APPROVAL
2004-08-20
LATEST ACTION
2017-11-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FEMTRACE · ReferenceDiscontinued
ESTRADIOL ACETATE 1.8MG · TABLET · ORAL
FEMTRACE · ReferenceDiscontinued
ESTRADIOL ACETATE 0.45MG · TABLET · ORAL
FEMTRACE · ReferenceDiscontinued
ESTRADIOL ACETATE 0.9MG · TABLET · ORAL

Approval history

2017-11-01Labeling · Supplement 6 · standard — Label ↗AP
2014-08-12Labeling · Supplement 5 · unknown — Letter ↗AP
2004-08-20Type 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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