← FDA DRUG APPROVALS

FDA NDA · NDA005292

ESTINYL

Sponsor: SCHERING

APPLICATION
NDA005292
TYPE
NDA
ORIGINAL APPROVAL
1943-06-25
LATEST ACTION
2001-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ESTINYLDiscontinued
ETHINYL ESTRADIOL 0.5MG · TABLET · ORAL
ESTINYLDiscontinued
ETHINYL ESTRADIOL 0.02MG · TABLET · ORAL
ESTINYLDiscontinued
ETHINYL ESTRADIOL 0.05MG · TABLET · ORAL

Approval history

2001-05-31Manufacturing (CMC) · Supplement 25AP
2001-03-23Manufacturing (CMC) · Supplement 24AP
2001-03-09Manufacturing (CMC) · Supplement 22AP
2000-12-04Manufacturing (CMC) · Supplement 21AP
2000-11-01Manufacturing (CMC) · Supplement 20AP
2000-08-18Manufacturing (CMC) · Supplement 19AP
1999-04-23Manufacturing (CMC) · Supplement 18AP
1998-11-06Manufacturing (CMC) · Supplement 17AP
1987-12-17Manufacturing (CMC) · Supplement 16AP
1986-06-26Labeling · Supplement 15AP
1986-03-27Labeling · Supplement 14AP
1980-06-11Manufacturing (CMC) · Supplement 12AP
1980-01-14Labeling · Supplement 11AP
1979-01-31Manufacturing (CMC) · Supplement 9AP
1978-10-20Labeling · Supplement 7AP
1943-06-25OriginalAP
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 →