← FDA DRUG APPROVALS

FDA NDA · NDA012151

ALDACTONE

spironolactone

Sponsor: PFIZER

APPLICATION
NDA012151
TYPE
NDA
ORIGINAL APPROVAL
1960-01-21
LATEST ACTION
2025-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALDACTONE · ReferencePrescription
SPIRONOLACTONE 25MG · TABLET · ORAL
ALDACTONE · ReferencePrescription
SPIRONOLACTONE 50MG · TABLET · ORAL
ALDACTONE · ReferencePrescription
SPIRONOLACTONE 100MG · TABLET · ORAL

Approval history

2025-11-14Labeling · Supplement 80 · standard — Label ↗AP
2022-12-19Labeling · Supplement 79 · standard — Label ↗AP
2020-07-28Labeling · Supplement 77 · standard — Letter ↗AP
2018-03-06Labeling · Supplement 75 · standard — Label ↗AP
2016-04-11Manufacturing (CMC) · Supplement 74 · priorityAP
2015-05-01Manufacturing (CMC) · Supplement 73 · priorityAP
2014-10-22Labeling · Supplement 72 · standard — Label ↗AP
2013-06-12Labeling · Supplement 71 · standard — Label ↗AP
2012-09-17Labeling · Supplement 68 · unknown — Letter ↗AP
2011-09-22Labeling · Supplement 67 · unknown — Letter ↗AP
2008-11-25Labeling · Supplement 62 · standard — Label ↗AP
2002-11-26Manufacturing (CMC) · Supplement 61 · priorityAP
1999-03-26Labeling · Supplement 60 · standardAP
1999-01-13Labeling · Supplement 59 · standardAP
1997-07-30Labeling · Supplement 35AP
1997-07-30Labeling · Supplement 56AP
1996-05-14Manufacturing (CMC) · Supplement 58 · priorityAP
1995-05-31Manufacturing (CMC) · Supplement 57 · priorityAP
1992-05-07Labeling · Supplement 55AP
1990-03-15Labeling · Supplement 53AP
1990-01-23Manufacturing (CMC) · Supplement 54 · priorityAP
1989-10-30Labeling · Supplement 52AP
1988-11-09Labeling · Supplement 50AP
1987-11-23Manufacturing (CMC) · Supplement 48 · priorityAP
1987-06-15Manufacturing (CMC) · Supplement 49 · priorityAP
1986-01-13Labeling · Supplement 47AP
1985-09-26Labeling · Supplement 46AP
1985-08-15Manufacturing (CMC) · Supplement 45 · priorityAP
1984-11-05Labeling · Supplement 44AP
1984-03-22Labeling · Supplement 43AP
1983-12-20Labeling · Supplement 42AP
1983-11-29Manufacturing (CMC) · Supplement 33 · priorityAP
1983-11-29Manufacturing (CMC) · Supplement 36 · priorityAP
1983-07-29Labeling · Supplement 41AP
1983-04-07Manufacturing (CMC) · Supplement 40 · priorityAP
1982-12-30Manufacturing (CMC) · Supplement 38 · priorityAP
1982-05-03Labeling · Supplement 37AP
1981-06-30Efficacy · Supplement 30AP
1981-06-22Manufacturing (CMC) · Supplement 34 · priorityAP
1981-03-04Manufacturing (CMC) · Supplement 31 · priorityAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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