APPLICATION
ANDA089424
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-23
LATEST ACTION
2025-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SPIRONOLACTONEPrescription
SPIRONOLACTONE 50MG · TABLET · ORAL
SPIRONOLACTONEPrescription
SPIRONOLACTONE 100MG · TABLET · ORAL
SPIRONOLACTONEPrescription
SPIRONOLACTONE 25MG · TABLET · ORAL
Approval history
2025-06-17Labeling · Supplement 66 · standardAP
2021-03-08Labeling · Supplement 62 · standardAP
2019-07-25Labeling · Supplement 58 · standardAP
2015-09-22Labeling · Supplement 55 · standardAP
2014-09-22Labeling · Supplement 53 · standardAP
2014-09-22Labeling · Supplement 52 · standardAP
2012-01-23Labeling · Supplement 49AP
2011-11-15Labeling · Supplement 51AP
2009-04-30Labeling · Supplement 48AP
2002-06-05Manufacturing (CMC) · Supplement 33AP
2002-06-05Manufacturing (CMC) · Supplement 32AP
2002-02-08Manufacturing (CMC) · Supplement 31AP
2001-07-13Manufacturing (CMC) · Supplement 27AP
2000-10-02Manufacturing (CMC) · Supplement 25AP
2000-10-02Labeling · Supplement 26AP
2000-05-16Manufacturing (CMC) · Supplement 24AP
2000-05-16Manufacturing (CMC) · Supplement 23AP
1999-08-11Manufacturing (CMC) · Supplement 22AP
1999-08-11Manufacturing (CMC) · Supplement 20AP
1999-08-11Manufacturing (CMC) · Supplement 19AP
1999-08-11Labeling · Supplement 21AP
1999-08-11Manufacturing (CMC) · Supplement 18AP
1998-12-07Manufacturing (CMC) · Supplement 17AP
1998-07-16Labeling · Supplement 16AP
1997-12-05Manufacturing (CMC) · Supplement 15AP
1997-02-24Manufacturing (CMC) · Supplement 14AP
1996-12-13Manufacturing (CMC) · Supplement 12AP
1996-12-13Manufacturing (CMC) · Supplement 13AP
1996-07-26Manufacturing (CMC) · Supplement 11AP
1996-02-12Labeling · Supplement 10AP
1995-06-22Manufacturing (CMC) · Supplement 9AP
1994-01-12Manufacturing (CMC) · Supplement 8AP
1993-05-07Labeling · Supplement 7AP
1991-08-16Labeling · Supplement 6AP
1990-11-08Manufacturing (CMC) · Supplement 4AP
1990-04-30Labeling · Supplement 5AP
1989-01-23Labeling · Supplement 3AP
1988-04-29Labeling · Supplement 2AP
1988-04-29Manufacturing (CMC) · Supplement 1AP
1986-07-23OriginalAP
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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