Prevents pregnancy. ANDA 79218, held by Watson Labs. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 79218 (Levonorgestrel And Ethinyl Estradiol), held by Watson Labs, was first approved by FDA on Jun 6, 2011, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Amethyst (levonorgestrel and ethinyl estradiol tablets) is 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 |
|---|---|---|---|
| Jun 6, 2011 | 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 12Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jun 16, 2016 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 6, 2011 | 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
