Kelnor 1/50

ANDA 72723, held by Watson Labs. Ethinyl Estradiol; Ethynodiol Diacetate.

As of Nov 15, 2026, ANDA 72723 (Kelnor 1/50), held by Watson Labs, was first approved by FDA on Dec 30, 1991, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1991
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Kelnor 1/500.05MG;1MG · tablet;oral-28	Ethinyl Estradiol; Ethynodiol Diacetate	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 44Labeling · Standard review	Approved	None posted
Sep 1, 2017	Supplement 38Labeling · Standard review	Approved	None posted
Aug 7, 2017	Supplement 37Labeling · Standard review	Approved	None posted
Oct 20, 2004	Supplement 15Labeling	Approved	None posted
Oct 18, 2002	Supplement 9Manufacturing	Approved	None posted
Sep 11, 2002	Supplement 5Labeling	Approved	None posted
Jul 30, 2002	Supplement 10Manufacturing	Approved	None posted
Oct 9, 2001	Supplement 8Manufacturing	Approved	None posted
Jan 29, 2001	Supplement 6Manufacturing	Approved	None posted
Apr 30, 1997	Supplement 4Labeling	Approved	None posted
Apr 10, 1996	Supplement 3Labeling	Approved	None posted
Sep 27, 1994	Supplement 2Labeling	Approved	None posted
Aug 12, 1993	Supplement 1Labeling	Approved	None posted
Dec 30, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 72723
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