Estradiol

ANDA 75233, held by Mylan Technologies. Estradiol.

As of Nov 14, 2026, ANDA 75233 (Estradiol), held by Mylan Technologies, was first approved by FDA on Feb 24, 2000, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 24, 2000
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Feb 24, 2000	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Estradiol0.05MG/24HR · film, extended release; transdermal	Estradiol	Rx

All 10 submissions, including labeling and manufacturing supplements


Jul 24, 2006	Supplement 12Labeling	Approved	None posted
Oct 6, 2005	Supplement 11Labeling	Approved	None posted
Mar 4, 2005	Supplement 10Labeling	Approved	None posted
Jan 21, 2005	Supplement 9Labeling	Approved	None posted
Jan 6, 2005	Supplement 7Labeling	Approved	None posted
Dec 23, 2002	Supplement 4Manufacturing	Approved	None posted
Dec 23, 2002	Supplement 3Manufacturing	Approved	None posted
Oct 25, 2001	Supplement 2Labeling	Approved	None posted
Nov 20, 2000	Supplement 1Manufacturing	Approved	None posted
Feb 24, 2000	Original application	Approved	Review Letter

Identifiers

Application: ANDA 75233
Drugs@FDA: Overview at FDA
Company: Mylan Technologies

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