← FDA DRUG APPROVALS

FDA NDA · NDA021166

ESTROGEL

estradiol

Sponsor: ASCEND THERAPS US

APPLICATION
NDA021166
TYPE
NDA
ORIGINAL APPROVAL
2004-02-09
LATEST ACTION
2024-02-15
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
GEL, METERED, GEL
MARKETING STATUS
Prescription, Discontinued

Products

ESTROGEL · ReferencePrescription
ESTRADIOL 0.06% (1.25GM/ACTIVATION) · GEL, METERED · TRANSDERMAL
ESTROGELDiscontinued
ESTRADIOL 0.06% · GEL · TOPICAL

Approval history

2024-02-15Labeling · Supplement 19 · standard — Letter ↗AP
2023-08-01Labeling · Supplement 18 · standard — Letter ↗AP
2021-11-30Labeling · Supplement 17 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 15 · standard — Label ↗AP
2015-06-11Manufacturing (CMC) · Supplement 13 · standardAP
2014-03-25Labeling · Supplement 10 · unknown — Label ↗AP
2012-11-14Manufacturing (CMC) · Supplement 12 · standardAP
2008-01-25Labeling · Supplement 7 · standard — Label ↗AP
2007-07-25Labeling · Supplement 5 · standard — Letter ↗AP
2006-10-04Manufacturing (CMC) · Supplement 4AP
2004-09-13Labeling · Supplement 1 · standard — Letter ↗AP
2004-02-09Type 3 - New Dosage Form · 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 →