Prevents pregnancy. ANDA 209548, held by Novast Labs. Ethinyl Estradiol; Ethynodiol Diacetate.
As of Nov 15, 2026, ANDA 209548 (Lo-Malmorede), held by Novast Labs, was first approved by FDA on Feb 11, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Zovia 1/35 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 |
|---|---|---|---|
| Feb 11, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lo-Malmorede0.035MG;1MG · tablet;oral-28 | Ethinyl Estradiol; Ethynodiol Diacetate | Rx |
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
