Estrace

ANDA 84500, held by Bristol Myers Squibb. Estradiol.

As of Nov 14, 2026, ANDA 84500 (Estrace), held by Bristol Myers Squibb, was first approved by FDA on Jul 23, 1975, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 23, 1975
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jul 23, 1975	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Estrace2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Estradiol	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Sep 12, 2005	Supplement 44Labeling	Approved	Label
Jan 25, 2001	Supplement 41Manufacturing	Approved	None posted
Oct 5, 1998	Supplement 39Labeling	Approved	None posted
Jul 28, 1997	Supplement 38Manufacturing	Approved	None posted
Jan 8, 1997	Supplement 37Labeling	Approved	None posted
Sep 11, 1995	Supplement 36Manufacturing	Approved	None posted
Jan 19, 1995	Supplement 35Manufacturing	Approved	None posted
Jan 19, 1995	Supplement 34Manufacturing	Approved	None posted
Jan 19, 1995	Supplement 33Manufacturing	Approved	None posted
Jan 19, 1995	Supplement 32Manufacturing	Approved	None posted
May 9, 1994	Supplement 31Labeling	Approved	None posted
Jan 12, 1993	Supplement 30Labeling	Approved	None posted
Nov 9, 1992	Supplement 25Manufacturing	Approved	None posted
Nov 9, 1992	Supplement 24Labeling	Approved	None posted
Nov 9, 1992	Supplement 23Manufacturing	Approved	None posted
Sep 8, 1992	Supplement 22Labeling	Approved	None posted
Aug 10, 1992	Supplement 29Labeling	Approved	None posted
Jul 18, 1989	Supplement 27Manufacturing	Approved	None posted
Jul 18, 1989	Supplement 26Manufacturing	Approved	None posted
Dec 19, 1985	Supplement 21Manufacturing	Approved	None posted
Mar 10, 1983	Supplement 17Manufacturing	Approved	None posted
Jun 7, 1982	Supplement 14Manufacturing	Approved	None posted
Jul 23, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 84500
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