Aldactone

Treats NYHA Class III–IV heart failure and reduced ejection fraction. NDA 12151, held by Pfizer. Spironolactone.

As of Nov 14, 2026, NDA 12151 (Aldactone), held by Pfizer, was first approved by FDA on Jan 21, 1960, with 41 approved supplements and 0 published complete response letters.

First approved: Jan 21, 1960
Review: Priority
Supplements approved: 41
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ALDACTONE 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 42 submissions below


Jun 30, 1981	Supplement 30Efficacy (new indication or use)	Approved	None posted
Jan 21, 1960	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


Aldactone50MG · tablet;oral	Spironolactone	RxReference drug
Aldactone25MG · tablet;oral	Spironolactone	RxReference drug
Aldactone100MG · tablet;oral	Spironolactone	RxReference drug

All 42 submissions, including labeling and manufacturing supplements


Nov 14, 2025	Supplement 80Labeling · Standard review	Approved	Letter Label
Dec 19, 2022	Supplement 79Labeling · Standard review	Approved	Label Letter
Jul 28, 2020	Supplement 77Labeling · Standard review	Approved	Label Letter
Mar 6, 2018	Supplement 75Labeling · Standard review	Approved	Letter Label
Apr 11, 2016	Supplement 74Manufacturing · Priority review	Approved	None posted
May 1, 2015	Supplement 73Manufacturing · Priority review	Approved	None posted
Oct 22, 2014	Supplement 72Labeling · Standard review	Approved	Label
Jun 12, 2013	Supplement 71Labeling · Standard review	Approved	Label Letter
Sep 17, 2012	Supplement 68Labeling	Approved	Letter Label
Sep 22, 2011	Supplement 67Labeling	Approved	Letter
Nov 25, 2008	Supplement 62Labeling · Standard review	Approved	Label Letter
Nov 26, 2002	Supplement 61Manufacturing · Priority review	Approved	None posted
Mar 26, 1999	Supplement 60Labeling · Standard review	Approved	None posted
Jan 13, 1999	Supplement 59Labeling · Standard review	Approved	None posted
Jul 30, 1997	Supplement 56Labeling	Approved	None posted
Jul 30, 1997	Supplement 35Labeling	Approved	None posted
May 14, 1996	Supplement 58Manufacturing · Priority review	Approved	None posted
May 31, 1995	Supplement 57Manufacturing · Priority review	Approved	None posted
May 7, 1992	Supplement 55Labeling	Approved	None posted
Mar 15, 1990	Supplement 53Labeling	Approved	None posted
Jan 23, 1990	Supplement 54Manufacturing · Priority review	Approved	None posted
Oct 30, 1989	Supplement 52Labeling	Approved	None posted
Nov 9, 1988	Supplement 50Labeling	Approved	None posted
Nov 23, 1987	Supplement 48Manufacturing · Priority review	Approved	None posted
Jun 15, 1987	Supplement 49Manufacturing · Priority review	Approved	None posted
Jan 13, 1986	Supplement 47Labeling	Approved	None posted
Sep 26, 1985	Supplement 46Labeling	Approved	None posted
Aug 15, 1985	Supplement 45Manufacturing · Priority review	Approved	None posted
Nov 5, 1984	Supplement 44Labeling	Approved	None posted
Mar 22, 1984	Supplement 43Labeling	Approved	None posted
Dec 20, 1983	Supplement 42Labeling	Approved	None posted
Nov 29, 1983	Supplement 36Manufacturing · Priority review	Approved	None posted
Nov 29, 1983	Supplement 33Manufacturing · Priority review	Approved	None posted
Jul 29, 1983	Supplement 41Labeling	Approved	None posted
Apr 7, 1983	Supplement 40Manufacturing · Priority review	Approved	None posted
Dec 30, 1982	Supplement 38Manufacturing · Priority review	Approved	None posted
May 3, 1982	Supplement 37Labeling	Approved	None posted
Jun 30, 1981	Supplement 30Efficacy (new indication or use)	Approved	None posted
Jun 22, 1981	Supplement 34Manufacturing · Priority review	Approved	None posted
Mar 4, 1981	Supplement 31Manufacturing · Priority review	Approved	None posted
Nov 10, 1976	Supplement 22Labeling	Approved	None posted
Jan 21, 1960	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 12151
Drugs@FDA: Overview at FDA
Company: Pfizer

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