Treats NYHA Class III-IV heart failure and reduced ejection fraction. NDA 209478, held by Cmp Dev LLC. Spironolactone.
As of Nov 13, 2026, NDA 209478 (Carospir), held by Cmp Dev LLC, was first approved by FDA on Aug 4, 2017, with 3 approved supplements and 0 published complete response letters.
Spironolactone oral suspension is an antagonist of aldosterone indicated for: the treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 2017 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carospir25MG/5ML · suspension;oral | Spironolactone | RxReference drug |
| Aug 24, 2023 | Supplement 6Labeling · Standard review | Approved | |
| Jul 15, 2021 | Supplement 2Manufacturing | Approved | |
| Jun 25, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Aug 4, 2017 | 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
