Prevents pregnancy. ANDA 219761, held by Annora Pharma. Desogestrel; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 219761 (Desogestrel And Ethinyl Estradiol), held by Annora Pharma, was first approved by FDA on Mar 18, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Desogestrel 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Desogestrel And Ethinyl Estradiol0.15MG;0.03MG · tablet;oral-28 | Desogestrel; Ethinyl Estradiol | Rx |
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
