Zovia 1/50e-21

ANDA 72722, held by Watson Labs. Ethinyl Estradiol; Ethynodiol Diacetate.

As of Nov 15, 2026, ANDA 72722 (Zovia 1/50e-21), held by Watson Labs, was first approved by FDA on Dec 30, 1991, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1991
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 30, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zovia 1/50e-210.05MG;1MG · tablet;oral-21	Ethinyl Estradiol; Ethynodiol Diacetate	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 27Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 26Labeling · Standard review	Approved	None posted
Oct 18, 2002	Supplement 10Manufacturing	Approved	None posted
Sep 11, 2002	Supplement 6Labeling	Approved	None posted
Jul 30, 2002	Supplement 11Manufacturing	Approved	None posted
Oct 9, 2001	Supplement 9Manufacturing	Approved	None posted
Jan 29, 2001	Supplement 7Manufacturing	Approved	None posted
Apr 30, 1997	Supplement 5Labeling	Approved	None posted
Apr 10, 1996	Supplement 4Labeling	Approved	None posted
Sep 27, 1994	Supplement 3Labeling	Approved	None posted
Aug 12, 1993	Supplement 2Labeling	Approved	None posted
May 17, 1993	Supplement 1Labeling	Approved	None posted
Dec 30, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 72722
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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