Low-Ogestrel-21, Low-Ogestrel-28

For a total. ANDA 75288, held by Dr Reddys Labs SA. Ethinyl Estradiol; Norgestrel.

As of Nov 15, 2026, ANDA 75288 (Low-Ogestrel-21, Low-Ogestrel-28), held by Dr Reddys Labs SA, was first approved by FDA on Jul 28, 1999, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 28, 1999
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jul 28, 1999	Original application	Approved	Label Review Letter

Products

2 strengths and forms


Low-Ogestrel-210.03MG;0.3MG · tablet;oral-21	Ethinyl Estradiol; Norgestrel	Discontinued
Low-Ogestrel-280.03MG;0.3MG · tablet;oral-28	Ethinyl Estradiol; Norgestrel	Rx

All 5 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 24Labeling · Standard review	Approved	None posted
Feb 28, 2022	Supplement 23Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 21Labeling · Standard review	Approved	None posted
Jun 24, 2005	Supplement 8Labeling	Approved	None posted
Jul 28, 1999	Original application	Approved	Label Review Letter

Identifiers

Application: ANDA 75288
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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