ANDA 203291, held by Pharmobedient. Drospirenone; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 203291 (Drospirenone And Ethinyl Estradiol), held by Pharmobedient, was first approved by FDA on Jul 18, 2017, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Drospirenone And Ethinyl Estradiol3MG;0.02MG · tablet;oral | Drospirenone; Ethinyl Estradiol | Rx |
| Jun 4, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 18, 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
