Treats NYHA Class III-IV heart failure and reduced ejection fraction. ANDA 219494, held by Graviti Pharms. Spironolactone.
As of Nov 15, 2026, ANDA 219494 (Spironolactone), held by Graviti Pharms, was first approved by FDA on Jan 23, 2025, with 1 approved supplement and 0 published complete response letters.
Spironolactone tablets are an aldosterone antagonist 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 23, 2025 | Original application | Approved | None posted |
| Spironolactone25MG · tablet;oral | Spironolactone | Rx |
| Spironolactone50MG · tablet;oral | Spironolactone | Rx |
| Spironolactone100MG · tablet;oral | Spironolactone | Rx |
| May 12, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 23, 2025 | 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
