Prevents pregnancy. ANDA 200248, held by Lupin. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 200248 (Levonorgestrel And Ethinyl Estradiol), held by Lupin, was first approved by FDA on Nov 19, 2015, with 3 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 I 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 and the IUD, 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 |
|---|---|---|---|
| Nov 19, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel And Ethinyl Estradiol0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Rx |
| Apr 29, 2022 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 22, 2020 | Supplement 7Manufacturing | Approved | None posted |
| Aug 9, 2017 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 19, 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
