Prevents pregnancy. ANDA 77681, held by Dr Reddys Labs SA. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 77681 (Levonorgestrel And Ethinyl Estradiol), held by Dr Reddys Labs SA, was first approved by FDA on May 31, 2006, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table III lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 31, 2006 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel And Ethinyl Estradiol0.02MG;0.1MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Rx |
| Apr 29, 2022 | Supplement 15Labeling · Standard review | Approved | None posted |
| Sep 14, 2017 | Supplement 12Labeling · Standard review | Approved | None posted |
| May 31, 2006 | Original application | Approved |
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
