APPLICATION
NDA007517
TYPE
NDA
ORIGINAL APPROVAL
1950-06-21
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TAPAZOLE · ReferenceDiscontinued
METHIMAZOLE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TAPAZOLE · ReferenceDiscontinued
METHIMAZOLE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2007-12-07Labeling · Supplement 5AP
2007-12-07Labeling · Supplement 14AP
2007-12-07Labeling · Supplement 10AP
2007-12-07Labeling · Supplement 6AP
2007-12-07Labeling · Supplement 11AP
1998-11-17Manufacturing (CMC) · Supplement 21 · priorityAP
1998-04-02Manufacturing (CMC) · Supplement 19 · priorityAP
1998-03-25Manufacturing (CMC) · Supplement 20 · priorityAP
1995-03-20Labeling · Supplement 18 · standardAP
1992-08-07Labeling · Supplement 17AP
1991-10-01Manufacturing (CMC) · Supplement 15 · priorityAP
1991-06-20Labeling · Supplement 16AP
1990-11-13Labeling · Supplement 12AP
1990-02-27Labeling · Supplement 13AP
1985-09-24Labeling · Supplement 9AP
1983-02-25Labeling · Supplement 8AP
1950-06-21Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.