APPLICATION
ANDA087398
TYPE
ANDA
ORIGINAL APPROVAL
1981-11-24
LATEST ACTION
1998-11-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, SPIRONOLACTONE 25MG · TABLET · ORAL
Approval history
1998-11-18Labeling · Supplement 23AP
1994-07-08Labeling · Supplement 21AP
1993-10-14Manufacturing (CMC) · Supplement 20AP
1993-04-22Manufacturing (CMC) · Supplement 19AP
1991-08-07Manufacturing (CMC) · Supplement 16AP
1991-08-06Labeling · Supplement 18AP
1991-01-28Manufacturing (CMC) · Supplement 17AP
1989-08-18Labeling · Supplement 14AP
1989-06-21Manufacturing (CMC) · Supplement 11AP
1989-06-21Manufacturing (CMC) · Supplement 12AP
1989-06-21Manufacturing (CMC) · Supplement 13AP
1985-10-04Manufacturing (CMC) · Supplement 5AP
1985-07-26Manufacturing (CMC) · Supplement 7AP
1985-07-26Manufacturing (CMC) · Supplement 6AP
1981-11-24OriginalAP
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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