APPLICATION
ANDA087665
TYPE
ANDA
ORIGINAL APPROVAL
1982-09-17
LATEST ACTION
2003-01-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFINPYRAZONEDiscontinued
SULFINPYRAZONE 100MG · TABLET · ORAL
Approval history
2003-01-02Labeling · Supplement 22AP
1999-12-21Manufacturing (CMC) · Supplement 21AP
1999-08-27Manufacturing (CMC) · Supplement 20AP
1999-05-20Manufacturing (CMC) · Supplement 19AP
1998-12-01Manufacturing (CMC) · Supplement 18AP
1994-12-23Manufacturing (CMC) · Supplement 17AP
1994-10-11Manufacturing (CMC) · Supplement 16AP
1992-04-03Manufacturing (CMC) · Supplement 15AP
1992-04-03Manufacturing (CMC) · Supplement 13AP
1991-06-12Labeling · Supplement 12AP
1991-03-08Labeling · Supplement 11AP
1989-07-14Labeling · Supplement 10AP
1987-03-20Manufacturing (CMC) · Supplement 8AP
1985-10-22Manufacturing (CMC) · Supplement 2AP
1985-10-22Manufacturing (CMC) · Supplement 3AP
1982-09-17OriginalAP
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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