← FDA DRUG APPROVALS

FDA NDA · NDA020992

CENESTIN

Sponsor: ASPEN

APPLICATION
NDA020992
TYPE
NDA
ORIGINAL APPROVAL
1999-03-24
LATEST ACTION
2026-02-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CENESTIN · ReferenceDiscontinued
ESTROGENS, CONJUGATED SYNTHETIC A 0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CENESTIN · ReferenceDiscontinued
ESTROGENS, CONJUGATED SYNTHETIC A 0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CENESTIN · ReferenceDiscontinued
ESTROGENS, CONJUGATED SYNTHETIC A 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CENESTIN · ReferenceDiscontinued
ESTROGENS, CONJUGATED SYNTHETIC A 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CENESTIN · ReferenceDiscontinued
ESTROGENS, CONJUGATED SYNTHETIC A 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2026-02-12Labeling · Supplement 43 · standard — Label ↗AP
2024-02-15Labeling · Supplement 41 · standard — Letter ↗AP
2020-11-30Labeling · Supplement 38 · standard — Label ↗AP
2020-11-30Labeling · Supplement 39 · standard — Label ↗AP
2017-11-01Labeling · Supplement 37 · standard — Label ↗AP
2015-03-20Labeling · Supplement 34 · unknown — Label ↗AP
2004-10-28Labeling · Supplement 26 · standard — Letter ↗AP
2004-02-05Efficacy · Supplement 21 · standard — Letter ↗AP
2004-01-28Labeling · Supplement 24 · standard — Letter ↗AP
2002-11-05Manufacturing (CMC) · Supplement 23 · standardAP
2002-10-18Manufacturing (CMC) · Supplement 22 · standardAP
2002-06-21Efficacy · Supplement 16 · standard — Label ↗AP
2002-04-29Manufacturing (CMC) · Supplement 20 · standardAP
2002-03-05Manufacturing (CMC) · Supplement 19 · standardAP
2002-02-22Labeling · Supplement 11 · standard — Letter ↗AP
2002-02-08Manufacturing (CMC) · Supplement 17 · standardAP
2002-02-08Manufacturing (CMC) · Supplement 18 · standardAP
2001-09-10Manufacturing (CMC) · Supplement 14 · standardAP
2001-09-05Manufacturing (CMC) · Supplement 15 · standardAP
2001-09-05Manufacturing (CMC) · Supplement 13 · standardAP
2001-07-20Manufacturing (CMC) · Supplement 12 · standardAP
2000-08-09Manufacturing (CMC) · Supplement 9 · standardAP
2000-03-13Manufacturing (CMC) · Supplement 6 · standardAP
2000-01-27Manufacturing (CMC) · Supplement 7 · standardAP
2000-01-07Manufacturing (CMC) · Supplement 5 · standardAP
1999-11-12Manufacturing (CMC) · Supplement 3 · standardAP
1999-11-08Manufacturing (CMC) · Supplement 4 · standardAP
1999-11-02Manufacturing (CMC) · Supplement 2 · standardAP
1999-09-07Manufacturing (CMC) · Supplement 1 · standardAP
1999-03-24Type 3 - New Dosage Form · Original · standard — Label ↗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 →