ANDA 201088, held by Xiromed. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 201088 (Vienva), held by Xiromed, was first approved by FDA on May 21, 2015, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of levonorgestrel and ethinyl estradiol in women with a body mass index (BMI) of > 35 kg/m 2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 21, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vienva0.02MG;0.1MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Rx |
| Apr 29, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 21, 2015 | 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
