Gynodiol

ANDA 40212, held by Duramed Pharms Barr. Estradiol.

As of Nov 14, 2026, ANDA 40212 (Gynodiol), held by Duramed Pharms Barr, was first approved by FDA on Dec 29, 1997, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1997
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 29, 1997	Original application	Approved	None posted

Products

4 strengths and forms


Gynodiol0.5MG · tablet;oral	Estradiol	Discontinued
Gynodiol1MG · tablet;oral	Estradiol	Discontinued
Gynodiol1.5MG · tablet;oral	Estradiol	Discontinued
Gynodiol2MG · tablet;oral	Estradiol	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Dec 12, 2002	Supplement 5Manufacturing	Approved	None posted
Dec 12, 2002	Supplement 6Manufacturing	Approved	None posted
Jun 19, 2002	Supplement 4Manufacturing	Approved	None posted
Oct 10, 2001	Supplement 2Manufacturing	Approved	None posted
May 16, 2000	Supplement 3Manufacturing	Approved	None posted
Dec 11, 1998	Supplement 1Labeling	Approved	None posted
Dec 29, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 40212
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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