← FDA DRUG APPROVALS

FDA NDA · NDA021490

FEMCON FE

Sponsor: APIL

APPLICATION
NDA021490
TYPE
NDA
ORIGINAL APPROVAL
2003-11-14
LATEST ACTION
2017-08-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FEMCON FE · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2017-08-09Labeling · Supplement 19 · standard — Label ↗AP
2016-09-22Labeling · Supplement 10 · standard — Label ↗AP
2016-07-08Manufacturing (CMC) · Supplement 17 · standardAP
2015-12-22Manufacturing (CMC) · Supplement 16 · standardAP
2015-09-03Manufacturing (CMC) · Supplement 15 · standardAP
2015-01-05Manufacturing (CMC) · Supplement 14 · standardAP
2013-08-06Manufacturing (CMC) · Supplement 13 · standardAP
2013-03-01Manufacturing (CMC) · Supplement 12 · standardAP
2008-01-09Labeling · Supplement 7 · standard — Letter ↗AP
2007-01-29Manufacturing (CMC) · Supplement 5 · standard — Letter ↗AP
2003-11-14Type 3 - New Dosage Form · Original · standard — Label ↗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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