Prevents pregnancy. ANDA 207055, held by Aurobindo Pharma. Ethinyl Estradiol; Norethindrone.
As of Nov 15, 2026, ANDA 207055 (Cyonanz), held by Aurobindo Pharma, was first approved by FDA on Oct 21, 2016, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cyonanz TM tablets 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 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 methods can result in lower failure rates.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyonanz0.035MG;0.5MG · tablet;oral-28 | Ethinyl Estradiol; Norethindrone | Rx |
| Apr 29, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 10, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 21, 2016 | 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
