APPLICATION
NDA015500
TYPE
NDA
ORIGINAL APPROVAL
1966-07-18
LATEST ACTION
1999-10-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOLINASE · ReferenceDiscontinued
TOLAZAMIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TOLINASE · ReferenceDiscontinued
TOLAZAMIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TOLINASE · ReferenceDiscontinued
TOLAZAMIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1999-10-28Labeling · Supplement 50 · standardAP
1987-06-25Labeling · Supplement 48AP
1987-06-25Labeling · Supplement 47AP
1986-07-11Manufacturing (CMC) · Supplement 46 · priorityAP
1986-03-24Labeling · Supplement 45AP
1984-10-03Labeling · Supplement 43AP
1983-05-09Manufacturing (CMC) · Supplement 42 · priorityAP
1978-02-24Labeling · Supplement 40AP
1975-12-01Manufacturing (CMC) · Supplement 34 · priorityAP
1966-07-18Type 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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