Prevents pregnancy. ANDA 209170, held by Naari Pte. Desogestrel; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 209170 (Desogestrel And Ethinyl Estradiol), held by Naari Pte, was first approved by FDA on Jun 5, 2017, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP is 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 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, 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 |
|---|---|---|---|
| Jun 5, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Desogestrel And Ethinyl Estradiol0.15MG,N/A;0.02MG,0.01MG · 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
