Estrace

ANDA 81295, held by Bristol Myers Squibb. Estradiol.

As of Nov 14, 2026, ANDA 81295 (Estrace), held by Bristol Myers Squibb, was first approved by FDA on Jun 30, 1993, with 11 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1993
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Jun 30, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Estrace0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Estradiol	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Sep 12, 2005	Supplement 14Labeling	Approved	Label
Jan 25, 2001	Supplement 11Manufacturing	Approved	None posted
Oct 5, 1998	Supplement 9Labeling	Approved	None posted
Jul 28, 1997	Supplement 8Manufacturing	Approved	None posted
Jan 8, 1997	Supplement 7Labeling	Approved	None posted
Jan 7, 1997	Supplement 3Labeling	Approved	None posted
Jan 7, 1997	Supplement 2Manufacturing	Approved	None posted
Oct 27, 1995	Supplement 6Manufacturing	Approved	None posted
Jun 6, 1995	Supplement 5Manufacturing	Approved	None posted
Feb 2, 1995	Supplement 4Manufacturing	Approved	None posted
May 9, 1994	Supplement 1Labeling	Approved	None posted
Jun 30, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 81295
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters