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FDA ANDA · ANDA089534
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Sponsor: SUN PHARM INDUSTRIES
APPLICATION
ANDA089534
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-02
LATEST ACTION
2026-05-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, SPIRONOLACTONE 25MG · TABLET · ORAL
Approval history
2026-05-12Labeling · Supplement 58 · standardAP
2023-05-17Labeling · Supplement 50 · standardAP
2023-05-17Labeling · Supplement 49 · standardAP
2023-05-17Labeling · Supplement 55 · standardAP
2019-11-01Labeling · Supplement 46 · standardAP
2015-03-20Labeling · Supplement 43 · standardAP
2014-09-24Labeling · Supplement 40 · standardAP
2014-09-24Labeling · Supplement 41 · standardAP
2011-12-14Labeling · Supplement 38AP
2011-12-14Labeling · Supplement 37AP
2002-01-31Manufacturing (CMC) · Supplement 19AP
2001-12-10Manufacturing (CMC) · Supplement 17AP
2001-02-14Labeling · Supplement 18AP
2000-05-16Manufacturing (CMC) · Supplement 16AP
2000-05-16Manufacturing (CMC) · Supplement 15AP
2000-02-01Labeling · Supplement 14AP
1998-07-28Labeling · Supplement 13AP
1997-12-05Manufacturing (CMC) · Supplement 12AP
1997-02-24Manufacturing (CMC) · Supplement 11AP
1996-08-01Manufacturing (CMC) · Supplement 10AP
1996-03-18Labeling · Supplement 9AP
1995-06-22Manufacturing (CMC) · Supplement 8AP
1995-04-05Labeling · Supplement 6AP
1995-04-05Manufacturing (CMC) · Supplement 7AP
1993-10-15Manufacturing (CMC) · Supplement 5AP
1993-10-15Manufacturing (CMC) · Supplement 3AP
1993-07-02Labeling · Supplement 4AP
1991-08-09Labeling · Supplement 2AP
1987-07-02OriginalAP
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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