APPLICATION
ANDA202068
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-07
LATEST ACTION
2021-10-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHIMAZOLEPrescription
METHIMAZOLE 5MG · TABLET · ORAL
METHIMAZOLEPrescription
METHIMAZOLE 10MG · TABLET · ORAL
Approval history
2021-10-20Labeling · Supplement 5 · standardAP
2019-01-23Labeling · Supplement 4 · standardAP
2016-01-15Labeling · Supplement 3 · standardAP
2012-03-07Not Applicable · OriginalAP
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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