APPLICATION
ANDA087086
TYPE
ANDA
ORIGINAL APPROVAL
1981-02-03
LATEST ACTION
2000-09-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SPIRONOLACTONEDiscontinued
SPIRONOLACTONE 25MG · TABLET · ORAL
Approval history
2000-09-13Labeling · Supplement 27AP
2000-04-03Labeling · Supplement 26AP
1998-08-26Labeling · Supplement 25AP
1998-02-25Manufacturing (CMC) · Supplement 23AP
1998-02-05Manufacturing (CMC) · Supplement 24AP
1994-06-01Manufacturing (CMC) · Supplement 22AP
1994-06-01Manufacturing (CMC) · Supplement 20AP
1994-06-01Manufacturing (CMC) · Supplement 21AP
1993-06-16Labeling · Supplement 19AP
1990-12-26Labeling · Supplement 17AP
1990-01-31Manufacturing (CMC) · Supplement 16AP
1987-11-10Manufacturing (CMC) · Supplement 14AP
1986-10-17Manufacturing (CMC) · Supplement 12AP
1985-04-10Manufacturing (CMC) · Supplement 9AP
1984-09-18Manufacturing (CMC) · Supplement 8AP
1981-12-02Manufacturing (CMC) · Supplement 3AP
1981-02-03OriginalAP
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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