← FDA DRUG APPROVALS

FDA NDA · NDA017876

LOESTRIN 21 1/20

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA017876
TYPE
NDA
ORIGINAL APPROVAL
1976-10-01
LATEST ACTION
2023-01-04
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LOESTRIN 21 1/20 · 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ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21

Approval history

2023-01-04Labeling · Supplement 40 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 39 · standard — Letter ↗AP
2017-08-09Labeling · Supplement 36 · standard — Label ↗AP
2014-09-26Manufacturing (CMC) · Supplement 33 · standardAP
2003-05-02Labeling · Supplement 31 · standard — Letter ↗AP
1999-11-24Labeling · Supplement 29 · standardAP
1999-03-31Labeling · Supplement 30 · standardAP
1999-01-08Labeling · Supplement 28 · standardAP
1998-01-16Labeling · Supplement 27 · standardAP
1997-11-20Manufacturing (CMC) · Supplement 26 · standardAP
1997-07-28Manufacturing (CMC) · Supplement 25 · standardAP
1997-07-28Manufacturing (CMC) · Supplement 24 · standardAP
1996-03-08Labeling · Supplement 17AP
1996-03-08Labeling · Supplement 20 · standardAP
1995-07-07Manufacturing (CMC) · Supplement 23 · standardAP
1994-06-27Manufacturing (CMC) · Supplement 21 · standardAP
1994-06-02Manufacturing (CMC) · Supplement 22 · standardAP
1994-03-07Manufacturing (CMC) · Supplement 19 · standardAP
1993-07-09Manufacturing (CMC) · Supplement 18 · standardAP
1991-04-22Labeling · Supplement 16AP
1989-05-17Manufacturing (CMC) · Supplement 15 · standardAP
1988-09-13Labeling · Supplement 13AP
1988-03-16Manufacturing (CMC) · Supplement 14 · standardAP
1986-06-04Labeling · Supplement 12AP
1985-09-17Manufacturing (CMC) · Supplement 10 · standardAP
1984-10-22Labeling · Supplement 11AP
1982-11-18Manufacturing (CMC) · Supplement 9 · standardAP
1978-06-14Manufacturing (CMC) · Supplement 4 · standardAP
1977-11-10Labeling · Supplement 5AP
1977-02-09Manufacturing (CMC) · Supplement 1 · standardAP
1977-02-09Manufacturing (CMC) · Supplement 2 · standardAP
1976-10-01Type 3 - New Dosage Form · 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 →