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FDA ANDA · ANDA087265

SPIRONOLACTONE

Sponsor: MUTUAL PHARM

APPLICATION
ANDA087265
TYPE
ANDA
ORIGINAL APPROVAL
1981-01-28
LATEST ACTION
1999-04-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SPIRONOLACTONEDiscontinued
SPIRONOLACTONE 25MG · TABLET · ORAL

Approval history

1999-04-22Labeling · Supplement 29AP
1998-12-01Manufacturing (CMC) · Supplement 28AP
1994-12-23Manufacturing (CMC) · Supplement 27AP
1994-10-11Manufacturing (CMC) · Supplement 26AP
1993-06-09Labeling · Supplement 25AP
1992-04-03Manufacturing (CMC) · Supplement 24AP
1992-04-03Manufacturing (CMC) · Supplement 22AP
1991-07-23Labeling · Supplement 21AP
1991-04-16Manufacturing (CMC) · Supplement 19AP
1991-04-16Manufacturing (CMC) · Supplement 17AP
1991-04-16Manufacturing (CMC) · Supplement 18AP
1991-04-16Manufacturing (CMC) · Supplement 16AP
1988-08-25Labeling · Supplement 15AP
1987-10-14Manufacturing (CMC) · Supplement 14AP
1987-03-31Manufacturing (CMC) · Supplement 13AP
1985-12-19Manufacturing (CMC) · Supplement 8AP
1983-06-03Manufacturing (CMC) · Supplement 6AP
1981-01-28OriginalAP
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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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