ANDA 202318, held by Sun Pharm. Drospirenone; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 202318 (Kyra), held by Sun Pharm, was first approved by FDA on Jul 23, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kyra3MG;0.02MG ยท tablet;oral | 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