ANDA 209407, held by Aurobindo Pharma Ltd. Drospirenone; Ethinyl Estradiol.
As of Nov 15, 2026, ANDA 209407 (Zumandimine), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 26, 2018, with 2 approved supplements and 0 published complete response letters.
Zumandimine (drospirenone and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zumandimine3MG;0.03MG · tablet;oral-28 | Drospirenone; Ethinyl Estradiol | Rx |
| Sep 19, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 26, 2018 | 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
