Prevents pregnancy. ANDA 207067, held by Naari Pte. Desogestrel; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 207067 (Desogestrel And Ethinyl Estradiol), held by Naari Pte, was first approved by FDA on Sep 13, 2018, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Desogestrel and ethinyl estradiol tablets USP 0.15 mg/0.03 mg 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 |
|---|---|---|---|
| Sep 13, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Desogestrel And Ethinyl Estradiol0.15MG;0.03MG · tablet;oral-28 | Desogestrel; Ethinyl Estradiol | Rx |
| Apr 29, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 13, 2018 | 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
