APPLICATION
NDA010670
TYPE
NDA
ORIGINAL APPROVAL
1957-05-31
LATEST ACTION
1987-10-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORINASEDiscontinued
TOLBUTAMIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ORINASEDiscontinued
TOLBUTAMIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1987-10-27Labeling · Supplement 48AP
1986-12-19Labeling · Supplement 46AP
1986-03-24Labeling · Supplement 45AP
1984-10-18Labeling · Supplement 44AP
1977-12-08Labeling · Supplement 34AP
1957-05-31Type 1 - New Molecular Entity · Original · priorityAP
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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