ANDA 203770, held by Xiromed. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 203770 (Jaimiess), held by Xiromed, was first approved by FDA on Dec 27, 2017, with 2 approved supplements and 0 published complete response letters.
Jaimiess is indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Jaimiess0.03MG,0.01MG;0.15MG,N/A · tablet;oral | Ethinyl Estradiol; Levonorgestrel | Rx |
| Nov 16, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 16, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 27, 2017 | 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
