ANDA 207245, held by Naari Pte. Drospirenone; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 207245 (Drospirenone And Ethinyl Estradiol), held by Naari Pte, was first approved by FDA on Nov 22, 2016, with 2 approved supplements and 0 published complete response letters.
Drospirenone and Ethinyl Estradiol Tablets USP is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Drospirenone And Ethinyl Estradiol3MG;0.03MG · tablet;oral-28 | Drospirenone; Ethinyl Estradiol | Rx |
| Oct 4, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 4, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 22, 2016 | 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
