APPLICATION
ANDA084339
TYPE
ANDA
ORIGINAL APPROVAL
1980-01-10
LATEST ACTION
1986-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PHENYLBUTAZONEDiscontinued
PHENYLBUTAZONE 100MG · TABLET · ORAL
Approval history
1986-12-19Manufacturing (CMC) · Supplement 29AP
1986-12-19Manufacturing (CMC) · Supplement 27AP
1986-12-19Manufacturing (CMC) · Supplement 28AP
1986-02-19Manufacturing (CMC) · Supplement 25AP
1986-02-19Manufacturing (CMC) · Supplement 26AP
1984-09-14Manufacturing (CMC) · Supplement 20AP
1984-09-14Manufacturing (CMC) · Supplement 22AP
1984-01-10Manufacturing (CMC) · Supplement 21AP
1982-12-23Manufacturing (CMC) · Supplement 18AP
1982-10-22Manufacturing (CMC) · Supplement 16AP
1982-08-26Manufacturing (CMC) · Supplement 14AP
1980-01-10OriginalAP
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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