Prevents pregnancy. ANDA 200245, held by Xiromed. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 200245 (Levonorgestrel And Ethinyl Estradiol), held by Xiromed, was first approved by FDA on Oct 9, 2013, with 3 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. Table 2 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, the IUD, and Norplant System, 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 |
|---|---|---|---|
| Oct 9, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel And Ethinyl Estradiol0.02MG;0.1MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Rx |
| Apr 29, 2022 | Supplement 8Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 28, 2017 | Supplement 1Manufacturing | Approved | None posted |
| Oct 9, 2013 | 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
