← FDA DRUG APPROVALS

FDA NDA · NDA021065

FEMHRT

Sponsor: APIL

APPLICATION
NDA021065
TYPE
NDA
ORIGINAL APPROVAL
1999-10-15
LATEST ACTION
2023-05-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FEMHRT · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.0025MG, NORETHINDRONE ACETATE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
FEMHRT · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.005MG, NORETHINDRONE ACETATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2023-05-18Labeling · Supplement 25 · standard — Letter ↗AP
2023-05-18Labeling · Supplement 26 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 24 · standard — Label ↗AP
2014-03-25Manufacturing (CMC) · Supplement 23 · standardAP
2014-01-08Labeling · Supplement 20 · unknown — Letter ↗AP
2013-09-13Manufacturing (CMC) · Supplement 21 · standardAP
2013-07-15Manufacturing (CMC) · Supplement 22 · standardAP
2005-01-14Efficacy · Supplement 12 · unknown — Label ↗AP
2004-01-20Labeling · Supplement 9 · standard — Label ↗AP
2000-12-19Manufacturing (CMC) · Supplement 6 · standardAP
2000-09-14Manufacturing (CMC) · Supplement 5 · standardAP
2000-07-14Labeling · Supplement 4 · standardAP
2000-07-03Manufacturing (CMC) · Supplement 2 · standardAP
2000-04-20Labeling · Supplement 3 · standardAP
2000-03-07Manufacturing (CMC) · Supplement 1 · standardAP
1999-10-15Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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