ANDA 206852, held by Aurobindo Pharma. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 206852 (Lo Simpesse), held by Aurobindo Pharma, was first approved by FDA on Apr 28, 2017, with 1 approved supplement and 0 published complete response letters.
Lo Simpesse TM (Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lo Simpesse0.02MG,0.1MG;0.01MG,N/A · tablet;oral | Ethinyl Estradiol; Levonorgestrel | Rx |
| Jun 20, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 28, 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
