← FDA DRUG APPROVALS

FDA NDA · NDA022573

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA022573
TYPE
NDA
ORIGINAL APPROVAL
2010-12-22
LATEST ACTION
2023-06-26
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.025MG, NORETHINDRONE 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL

Approval history

2023-06-26Labeling · Supplement 12 · standard — Label ↗AP
2022-04-29Labeling · Supplement 14 · standard — Letter ↗AP
2017-08-09Labeling · Supplement 8 · standard — Label ↗AP
2013-12-11Manufacturing (CMC) · Supplement 1 · standardAP
2013-08-12Manufacturing (CMC) · Supplement 4 · standardAP
2013-08-12Manufacturing (CMC) · Supplement 5 · standardAP
2013-03-13Manufacturing (CMC) · Supplement 3 · standardAP
2010-12-22Type 5 - New Formulation or New Manufacturer · 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →