← FDA DRUG APPROVALS

FDA NDA · NDA012616

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

Sponsor: PFIZER

APPLICATION
NDA012616
TYPE
NDA
ORIGINAL APPROVAL
1961-01-27
LATEST ACTION
2025-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

ALDACTAZIDE · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 50MG, SPIRONOLACTONE 50MG · TABLET · ORAL
ALDACTAZIDE · ReferencePrescription
HYDROCHLOROTHIAZIDE 25MG, SPIRONOLACTONE 25MG · TABLET · ORAL

Approval history

2025-11-14Labeling · Supplement 85 · standard — Label ↗AP
2022-12-19Labeling · Supplement 83 · standard — Label ↗AP
2021-02-19Labeling · Supplement 81 · standard — Label ↗AP
2020-08-20Labeling · Supplement 80 · standard — Letter ↗AP
2019-01-17Labeling · Supplement 78 · standard — Label ↗AP
2014-10-22Labeling · Supplement 76 · standard — Label ↗AP
2014-03-06Labeling · Supplement 75 · standard — Letter ↗AP
2014-01-17Labeling · Supplement 74 · standard — Letter ↗AP
2013-06-14Manufacturing (CMC) · Supplement 72AP
2013-06-12Labeling · Supplement 73 · standard — Label ↗AP
2011-09-22Labeling · Supplement 69 · unknown — Letter ↗AP
2011-05-19Labeling · Supplement 68 · unknown — Label ↗AP
2002-11-26Manufacturing (CMC) · Supplement 63AP
1999-04-21Labeling · Supplement 62 · standardAP
1999-01-13Labeling · Supplement 61 · standardAP
1997-11-13Labeling · Supplement 58AP
1997-11-13Labeling · Supplement 37AP
1990-01-23Manufacturing (CMC) · Supplement 55AP
1978-01-04REMS · Supplement 16AP
1961-01-27Type 4 - New Combination · Original · standardAP
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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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