APPLICATION
ANDA040750
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-29
LATEST ACTION
2023-06-23
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
2023-06-23Labeling · Supplement 29 · standardAP
2021-02-26Labeling · Supplement 26 · standardAP
2015-10-30Labeling · Supplement 17 · standardAP
2014-09-22Labeling · Supplement 7AP
2014-09-22Labeling · Supplement 15 · standardAP
2014-09-22Labeling · Supplement 12 · standardAP
2011-10-31Labeling · Supplement 3AP
2006-08-29OriginalAP
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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