APPLICATION
ANDA040411
TYPE
ANDA
ORIGINAL APPROVAL
2001-03-27
LATEST ACTION
2025-07-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHIMAZOLEPrescription
METHIMAZOLE 10MG · TABLET · ORAL
METHIMAZOLEPrescription
METHIMAZOLE 5MG · TABLET · ORAL
Approval history
2025-07-21Labeling · Supplement 29 · standardAP
2019-01-18Labeling · Supplement 28 · standardAP
2016-01-15Labeling · Supplement 25 · standardAP
2012-07-11Labeling · Supplement 15 · standardAP
2011-08-22Labeling · Supplement 13AP
2011-03-28Labeling · Supplement 12AP
2002-01-08Manufacturing (CMC) · Supplement 2AP
2001-07-26Labeling · Supplement 1AP
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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