Treats NYHA Class III-IV heart failure and reduced ejection fraction. ANDA 202187, held by Aurobindo Pharma. Spironolactone.
As of Nov 15, 2026, ANDA 202187 (Spironolactone), held by Aurobindo Pharma, was first approved by FDA on Mar 6, 2014, with 5 approved supplements and 0 published complete response letters.
Spironolactone is 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 |
|---|---|---|---|
| Mar 6, 2014 | Original application | Approved | None posted |
| Spironolactone25MG · tablet;oral | Spironolactone | Rx |
| Spironolactone50MG · tablet;oral | Spironolactone | Rx |
| Spironolactone100MG · tablet;oral | Spironolactone | Rx |
| Aug 11, 2026 | Supplement 10Labeling · Standard review | Approved | None posted |
| Feb 28, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 2, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 2, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 30, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 6, 2014 | 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
