APPLICATION
ANDA040424
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-20
LATEST ACTION
2023-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SPIRONOLACTONEPrescription
SPIRONOLACTONE 100MG · TABLET · ORAL
SPIRONOLACTONEPrescription
SPIRONOLACTONE 25MG · TABLET · ORAL
SPIRONOLACTONEPrescription
SPIRONOLACTONE 50MG · TABLET · ORAL
Approval history
2023-10-10Labeling · Supplement 33 · standardAP
2021-02-26Labeling · Supplement 30 · standardAP
2019-11-14Labeling · Supplement 21 · standardAP
2015-04-26Labeling · Supplement 18 · standardAP
2014-09-23Labeling · Supplement 17 · standardAP
2014-09-23Labeling · Supplement 16 · standardAP
2009-02-25Labeling · Supplement 11AP
2003-06-09Labeling · Supplement 4AP
2002-05-21Manufacturing (CMC) · Supplement 1AP
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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