Estradurin

NDA 10753, held by Wyeth Ayerst. Polyestradiol Phosphate.

As of Nov 13, 2026, NDA 10753 (Estradurin), held by Wyeth Ayerst, was first approved by FDA on Apr 17, 1957, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 17, 1957
Review: Standard
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
Sep 1, 1981	Supplement 12Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 15, 1981	Supplement 11Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 13, 1979	Supplement 10Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 13, 1979	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 13, 1979	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 17, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Estradurin40MG/AMP · injectable;injection	Polyestradiol Phosphate	Discontinued

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 6, 1990	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 14, 1989	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 19, 1985	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 1, 1981	Supplement 12Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 15, 1981	Supplement 11Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 13, 1979	Supplement 10Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 13, 1979	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 13, 1979	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 17, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 10753
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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