NDA 216285, held by Exeltis USA Inc. Drospirenone.
As of Nov 14, 2026, NDA 216285 (Drospirenone), held by Exeltis USA Inc, was first approved by FDA on Jun 29, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2022 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Drospirenone3.5MG · tablet, chewable;oral | Drospirenone | DiscontinuedReference drug |
| Dec 19, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Jun 29, 2022 | Original applicationNew dosage form · Standard review | Approved |
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
