ANDA 202138, held by Sun Pharm. Drospirenone; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 202138 (Kemeya), held by Sun Pharm, was first approved by FDA on Mar 13, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 13, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kemeya3MG;0.03MG ยท tablet;oral-28 | Drospirenone; Ethinyl Estradiol | Discontinued |
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
