Ogestrel 0.5/50-21, Ogestrel 0.5/50-28

ANDA 75406, held by Watson Labs. Ethinyl Estradiol; Norgestrel.

As of Nov 15, 2026, ANDA 75406 (Ogestrel 0.5/50-21, Ogestrel 0.5/50-28), held by Watson Labs, was first approved by FDA on Dec 15, 1999, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 15, 1999
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 15, 1999	Original application	Approved	Letter

Products

2 strengths and forms


Ogestrel 0.5/50-210.05MG;0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-21	Ethinyl Estradiol; Norgestrel	Discontinued
Ogestrel 0.5/50-280.05MG;0.5MG · tablet;oral-28	Ethinyl Estradiol; Norgestrel	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 24Labeling · Standard review	Approved	None posted
Jul 19, 2017	Supplement 23Labeling · Standard review	Approved	None posted
Dec 4, 2008	Supplement 16Labeling	Approved	Letter Label
Oct 4, 2006	Supplement 11Labeling	Approved	None posted
Dec 15, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 75406
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