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FDA ANDA · ANDA087267

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

Sponsor: MUTUAL PHARM

APPLICATION
ANDA087267
TYPE
ANDA
ORIGINAL APPROVAL
1981-04-16
LATEST ACTION
1999-04-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, SPIRONOLACTONE 25MG · TABLET · ORAL

Approval history

1999-04-22Labeling · Supplement 27AP
1998-12-01Manufacturing (CMC) · Supplement 26AP
1994-12-23Manufacturing (CMC) · Supplement 25AP
1994-10-11Manufacturing (CMC) · Supplement 24AP
1994-07-14Labeling · Supplement 23AP
1992-04-03Manufacturing (CMC) · Supplement 22AP
1992-04-03Manufacturing (CMC) · Supplement 20AP
1991-05-07Labeling · Supplement 19AP
1989-10-30Labeling · Supplement 17AP
1987-09-15Manufacturing (CMC) · Supplement 15AP
1987-04-01Manufacturing (CMC) · Supplement 14AP
1986-08-18Manufacturing (CMC) · Supplement 13AP
1985-12-18Manufacturing (CMC) · Supplement 7AP
1985-12-18Manufacturing (CMC) · Supplement 11AP
1985-12-18Manufacturing (CMC) · Supplement 12AP
1985-12-18Manufacturing (CMC) · Supplement 10AP
1983-03-23Manufacturing (CMC) · Supplement 6AP
1981-04-16OriginalAP
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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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