Prevents pregnancy. ANDA 202791, held by Glenmark Pharms Ltd. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 202791 (Levonorgestrel And Ethinyl Estradiol), held by Glenmark Pharms Ltd, was first approved by FDA on Apr 9, 2015, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 9, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel And Ethinyl Estradiol0.02MG;0.09MG · tablet;oral | Ethinyl Estradiol; Levonorgestrel | Rx |
| Apr 29, 2022 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 18, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 16, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 9, 2015 | Original application | Approved | None posted |
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
