Estrace

ANDA 84499, held by Bristol Myers Squibb. Estradiol.

As of Nov 14, 2026, ANDA 84499 (Estrace), held by Bristol Myers Squibb, was first approved by FDA on Jul 28, 1975, with 21 approved supplements and 0 published complete response letters.

First approved: Jul 28, 1975
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Jul 28, 1975	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Estrace1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Estradiol	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements


Sep 12, 2005	Supplement 42Labeling	Approved	Label
Jan 25, 2001	Supplement 39Manufacturing	Approved	None posted
Oct 5, 1998	Supplement 37Labeling	Approved	None posted
Jul 28, 1997	Supplement 36Manufacturing	Approved	None posted
Jan 8, 1997	Supplement 35Labeling	Approved	None posted
Sep 11, 1995	Supplement 34Manufacturing	Approved	None posted
Jan 19, 1995	Supplement 33Manufacturing	Approved	None posted
Jan 19, 1995	Supplement 32Manufacturing	Approved	None posted
Jan 19, 1995	Supplement 31Manufacturing	Approved	None posted
Jan 19, 1995	Supplement 30Manufacturing	Approved	None posted
May 9, 1994	Supplement 29Labeling	Approved	None posted
Jan 12, 1993	Supplement 28Labeling	Approved	None posted
Nov 9, 1992	Supplement 24Manufacturing	Approved	None posted
Nov 9, 1992	Supplement 23Labeling	Approved	None posted
Nov 9, 1992	Supplement 22Manufacturing	Approved	None posted
Sep 8, 1992	Supplement 21Labeling	Approved	None posted
Aug 10, 1992	Supplement 27Labeling	Approved	None posted
Jun 30, 1989	Supplement 26Manufacturing	Approved	None posted
Dec 19, 1985	Supplement 19Manufacturing	Approved	None posted
Mar 10, 1983	Supplement 13Manufacturing	Approved	None posted
Jun 4, 1982	Supplement 12Manufacturing	Approved	None posted
Jul 28, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 84499
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