← FDA DRUG APPROVALS

FDA ANDA · ANDA207260

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Sponsor: XIROMED

APPLICATION
ANDA207260
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-02
LATEST ACTION
2024-02-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLDiscontinued
ETHINYL ESTRADIOL 0.0025MG, NORETHINDRONE ACETATE 0.5MG · TABLET · ORAL

Approval history

2024-02-16Labeling · Supplement 4 · standardAP
2024-01-26Labeling · Supplement 1 · standardAP
2024-01-26Labeling · Supplement 3 · standardAP
2017-02-02UNKNOWN · Original · standardAP
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 →