Prevents pregnancy. ANDA 76785, held by Barr. Ethinyl Estradiol; Ethynodiol Diacetate.
As of Nov 15, 2026, ANDA 76785 (Kelnor), held by Barr, was first approved by FDA on May 23, 2005, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets) 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 combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 23, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kelnor0.035MG;1MG · tablet;oral-28 | Ethinyl Estradiol; Ethynodiol Diacetate | Rx |
| Apr 29, 2022 | Supplement 20Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 15Labeling · Standard review | Approved | None posted |
| May 23, 2005 | 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
