APPLICATION
ANDA086809
TYPE
ANDA
ORIGINAL APPROVAL
1980-07-10
LATEST ACTION
2015-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SPIRONOLACTONEDiscontinued
SPIRONOLACTONE 25MG · TABLET · ORAL
Approval history
2015-05-19Labeling · Supplement 69 · standardAP
2014-09-22Labeling · Supplement 66 · standardAP
2014-09-22Labeling · Supplement 67 · standardAP
2014-09-22Labeling · Supplement 65 · standardAP
2009-02-25Labeling · Supplement 62AP
2002-12-16Manufacturing (CMC) · Supplement 52AP
2002-09-17Manufacturing (CMC) · Supplement 51AP
2001-05-09Manufacturing (CMC) · Supplement 50AP
2001-01-11Manufacturing (CMC) · Supplement 48AP
2000-09-13Labeling · Supplement 49AP
2000-02-17Manufacturing (CMC) · Supplement 47AP
1999-05-05Manufacturing (CMC) · Supplement 46AP
1998-06-10Labeling · Supplement 45AP
1997-10-21Manufacturing (CMC) · Supplement 44AP
1996-05-16Labeling · Supplement 43AP
1995-12-01Manufacturing (CMC) · Supplement 42AP
1995-01-24Labeling · Supplement 41AP
1994-06-20Manufacturing (CMC) · Supplement 40AP
1991-04-22Labeling · Supplement 39AP
1988-04-20Manufacturing (CMC) · Supplement 38AP
1988-04-20Manufacturing (CMC) · Supplement 37AP
1987-01-30Manufacturing (CMC) · Supplement 33AP
1987-01-30Manufacturing (CMC) · Supplement 34AP
1987-01-30Manufacturing (CMC) · Supplement 35AP
1986-08-29Manufacturing (CMC) · Supplement 30AP
1986-08-29Manufacturing (CMC) · Supplement 29AP
1986-08-26Manufacturing (CMC) · Supplement 31AP
1986-08-15Manufacturing (CMC) · Supplement 28AP
1984-07-02Manufacturing (CMC) · Supplement 26AP
1983-08-05Manufacturing (CMC) · Supplement 25AP
1983-08-05Manufacturing (CMC) · Supplement 24AP
1983-01-27Manufacturing (CMC) · Supplement 23AP
1983-01-27Manufacturing (CMC) · Supplement 22AP
1982-05-24Manufacturing (CMC) · Supplement 20AP
1982-04-26Manufacturing (CMC) · Supplement 21AP
1980-07-10OriginalAP
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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