APPLICATION
ANDA203512
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-19
LATEST ACTION
2026-05-12
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
2026-05-12Labeling · Supplement 12 · standardAP
2026-05-12Labeling · Supplement 11 · standardAP
2023-04-25Labeling · Supplement 8 · standardAP
2021-02-26Labeling · Supplement 5 · standardAP
2019-08-05Labeling · Supplement 2 · standardAP
2016-09-19UNKNOWN · OriginalAP
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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