Prevents pregnancy. ANDA 207065, held by Naari Pte. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 207065 (Levonorgestrel And Ethinyl Estradiol), held by Naari Pte, was first approved by FDA on Aug 17, 2020, with 1 approved supplement 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 II 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 |
|---|---|---|---|
| Aug 17, 2020 | 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 1Labeling · Standard review | Approved | None posted |
| Aug 17, 2020 | 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
