APPLICATION
ANDA040734
TYPE
ANDA
ORIGINAL APPROVAL
2007-12-14
LATEST ACTION
2025-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHIMAZOLEPrescription
METHIMAZOLE 5MG · TABLET · ORAL
METHIMAZOLEPrescription
METHIMAZOLE 10MG · TABLET · ORAL
Approval history
2025-08-26Labeling · Supplement 9 · standardAP
2019-01-18Labeling · Supplement 7 · standardAP
2016-01-15Labeling · Supplement 3 · standardAP
2007-12-14OriginalAP
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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