APPLICATION
ANDA088994
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-04
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PHENYLBUTAZONEDiscontinued
PHENYLBUTAZONE 100MG · CAPSULE · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 15AP
1994-12-23Manufacturing (CMC) · Supplement 14AP
1994-10-11Manufacturing (CMC) · Supplement 13AP
1992-04-03Manufacturing (CMC) · Supplement 12AP
1992-04-03Manufacturing (CMC) · Supplement 10AP
1989-11-20Labeling · Supplement 9AP
1989-06-28Labeling · Supplement 8AP
1988-03-03Manufacturing (CMC) · Supplement 6AP
1987-07-14Manufacturing (CMC) · Supplement 2AP
1987-04-01Manufacturing (CMC) · Supplement 5AP
1986-06-06Manufacturing (CMC) · Supplement 3AP
1985-12-04OriginalAP
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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