Prevents pregnancy. ANDA 76625, held by Dr Reddys Labs SA. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 76625 (Levonorgestrel And Ethinyl Estradiol), held by Dr Reddys Labs SA, was first approved by FDA on Nov 18, 2004, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Lutera 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. 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 |
|---|---|---|---|
| Nov 18, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel And Ethinyl Estradiol0.02MG;0.1MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Rx |
| May 22, 2025 | Supplement 18Labeling · Standard review | Approved | None posted |
| Apr 29, 2022 | Supplement 17Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jul 30, 2012 | Supplement 10Labeling | Approved | |
| Nov 18, 2004 | 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
