← FDA DRUG APPROVALS

FDA NDA · NDA021871

LOESTRIN 24 FE

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA021871
TYPE
NDA
ORIGINAL APPROVAL
2006-02-17
LATEST ACTION
2023-01-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LOESTRIN 24 FE · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2023-01-04Labeling · Supplement 13 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 12 · standard — Letter ↗AP
2021-09-02Labeling · Supplement 10 · standard — Letter ↗AP
2017-08-09Labeling · Supplement 8 · standard — Label ↗AP
2016-08-22Labeling · Supplement 1 · standard — Label ↗AP
2016-04-19Manufacturing (CMC) · Supplement 6 · standardAP
2013-05-01Manufacturing (CMC) · Supplement 4 · standardAP
2010-09-10Manufacturing (CMC) · Supplement 2AP
2006-02-17Type 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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