Prevents pregnancy. ANDA 75803, held by Barr. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 75803 (Lessina-21, Lessina-28), held by Barr, was first approved by FDA on Mar 20, 2002, with 6 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Oral contraceptives are 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 III 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 methods can result in lower failure rates. TABLE III.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 2002 | Original application | Approved |
| Lessina-210.02MG;0.1MG · tablet;oral-21 | Ethinyl Estradiol; Levonorgestrel | Discontinued |
| Lessina-280.02MG;0.1MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Rx |
| Apr 29, 2022 | Supplement 34Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 29Labeling · Standard review | Approved | None posted |
| Nov 27, 2002 | Supplement 4Manufacturing | Approved | None posted |
| Sep 30, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Sep 30, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Sep 30, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Mar 20, 2002 | 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
