APPLICATION
NDA016096
TYPE
NDA
ORIGINAL APPROVAL
1967-04-07
LATEST ACTION
2003-06-11
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
MINTEZOLDiscontinued
THIABENDAZOLE 500MG · TABLET, CHEWABLE · ORAL
Approval history
2002-10-24Manufacturing (CMC) · Supplement 32 · priorityAP
2002-03-27Manufacturing (CMC) · Supplement 31 · priorityAP
1996-08-07Manufacturing (CMC) · Supplement 29 · priorityAP
1996-06-03Labeling · Supplement 24AP
1995-12-26Manufacturing (CMC) · Supplement 28 · priorityAP
1994-06-16Manufacturing (CMC) · Supplement 27 · priorityAP
1992-07-01Manufacturing (CMC) · Supplement 26 · priorityAP
1991-12-30Manufacturing (CMC) · Supplement 25 · priorityAP
1990-11-19Manufacturing (CMC) · Supplement 23 · priorityAP
1990-04-04Manufacturing (CMC) · Supplement 22 · priorityAP
1987-04-06Labeling · Supplement 17AP
1985-10-18Labeling · Supplement 21AP
1985-04-01Labeling · Supplement 16AP
1985-01-23Manufacturing (CMC) · Supplement 20 · priorityAP
1984-08-09Manufacturing (CMC) · Supplement 18 · priorityAP
1983-11-07Labeling · Supplement 15AP
1983-11-07Labeling · Supplement 14AP
1981-06-04Manufacturing (CMC) · Supplement 13 · priorityAP
1978-04-17Labeling · Supplement 12AP
1977-05-03Labeling · Supplement 11AP
1976-06-24Manufacturing (CMC) · Supplement 9 · priorityAP
1976-04-15Labeling · Supplement 8AP
1975-02-25Manufacturing (CMC) · Supplement 7 · priorityAP
1967-04-07Type 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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