APPLICATION
ANDA040353
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-29
LATEST ACTION
2015-09-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SPIRONOLACTONEDiscontinued
SPIRONOLACTONE 100MG · TABLET · ORAL
SPIRONOLACTONEDiscontinued
SPIRONOLACTONE 25MG · TABLET · ORAL
SPIRONOLACTONEDiscontinued
SPIRONOLACTONE 50MG · TABLET · ORAL
Approval history
2015-09-22Labeling · Supplement 38 · standardAP
2014-09-22Labeling · Supplement 35 · standardAP
2011-11-28Labeling · Supplement 31AP
2009-06-11Labeling · Supplement 26AP
2009-04-30Labeling · Supplement 25AP
2006-03-15Labeling · Supplement 8AP
2006-03-15Supplement · Supplement 7AP
2001-11-02Manufacturing (CMC) · Supplement 2AP
2001-03-05Manufacturing (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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