Prevents pregnancy. ANDA 204704, held by Xiromed. Ethinyl Estradiol; Ethynodiol Diacetate.
As of Nov 15, 2026, ANDA 204704 (Ethynodiol Diacetate And Ethinyl Estradiol), held by Xiromed, was first approved by FDA on Feb 9, 2016, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Valtya 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Valtya 1/50, which contain 50 mcg of estrogen, should not be used unless medically indicated. 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 |
|---|---|---|---|
| Feb 9, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ethynodiol Diacetate And Ethinyl Estradiol0.05MG;1MG · tablet;oral-28 | Ethinyl Estradiol; Ethynodiol Diacetate | Rx |
| Apr 29, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 9, 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
