Prevents pregnancy. ANDA 206886, held by Aurobindo Pharma. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 206886 (Afirmelle), held by Aurobindo Pharma, was first approved by FDA on Nov 14, 2016, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Afirmelle 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 14, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Afirmelle0.02MG;0.1MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Rx |
| Apr 29, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 14, 2016 | 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
