APPLICATION
NDA008319
TYPE
NDA
ORIGINAL APPROVAL
1997-06-25
LATEST ACTION
1997-06-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET
MARKETING STATUS
Discontinued
Products
BUTAZOLIDINDiscontinued
PHENYLBUTAZONE 100MG · CAPSULE · ORAL
BUTAZOLIDINDiscontinued
PHENYLBUTAZONE 100MG · TABLET · ORAL
Approval history
1997-06-25Labeling · Supplement 46AP
1997-06-25Labeling · Supplement 89AP
1997-06-25Labeling · Supplement 79AP
1997-06-25Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standardAP
1997-06-25Labeling · Supplement 77AP
1997-06-25Labeling · Supplement 81AP
1997-06-25Labeling · Supplement 59AP
1997-06-25Labeling · Supplement 57AP
1997-06-25Labeling · Supplement 90AP
1997-06-25Labeling · Supplement 72AP
1989-01-03Labeling · Supplement 88AP
1988-09-13Labeling · Supplement 87AP
1985-09-30Labeling · Supplement 85AP
1985-03-04Labeling · Supplement 83AP
1979-08-06Labeling · Supplement 64AP
1977-08-22Labeling · Supplement 58AP
1977-05-18Labeling · Supplement 52AP
1977-05-16Labeling · Supplement 49AP
1977-05-16Labeling · Supplement 56AP
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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