Prevents pregnancy. ANDA 91234, held by Novast Labs. Desogestrel; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 91234 (Desogestrel And Ethinyl Estradiol), held by Novast Labs, was first approved by FDA on Jul 12, 2013, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Desogestrel and ethinyl estradiol tablets, USP 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 I 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 |
|---|---|---|---|
| Jul 12, 2013 | 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 12Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 5Labeling · Standard review | Approved | None posted |
| May 26, 2016 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 1, 2014 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 12, 2013 | 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
