Prevents pregnancy. ANDA 75256, held by Duramed Pharms Barr. Desogestrel; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 75256 (Desogestrel And Ethinyl Estradiol), held by Duramed Pharms Barr, was first approved by FDA on Aug 12, 1999, with 13 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Apri (desogestrel and ethinyl estradiol tablets USP) 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 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 |
|---|---|---|---|
| Aug 12, 1999 | Original application | Approved |
| Desogestrel And Ethinyl Estradiol0.15MG;0.03MG · tablet;oral-21 | Desogestrel; Ethinyl Estradiol | Discontinued |
| Desogestrel And Ethinyl Estradiol0.15MG;0.03MG · tablet;oral-28 | Desogestrel; Ethinyl Estradiol | Rx |
| Apr 29, 2022 | Supplement 41Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 36Labeling · Standard review | Approved | None posted |
| May 26, 2016 | Supplement 34Labeling · Standard review | Approved | None posted |
| Apr 13, 2015 | Supplement 33Labeling · Standard review | Approved | None posted |
| Jan 31, 2013 | Supplement 29Labeling · Standard review | Approved | None posted |
| Nov 26, 2004 | Supplement 8Labeling | Approved | None posted |
| Jun 19, 2002 | Supplement 7Manufacturing | Approved | |
| Nov 14, 2001 | Supplement 3Manufacturing | Approved | |
| Jul 27, 2001 | Supplement 5Manufacturing | Approved | |
| Jul 27, 2001 | Supplement 6Manufacturing | Approved | |
| Jul 11, 2001 | Supplement 4Manufacturing | Approved | |
| Jun 28, 2001 | Supplement 2Manufacturing | Approved | |
| Oct 28, 1999 | Supplement 1Labeling | Approved | |
| Aug 12, 1999 | Original application | Approved |
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
