APPLICATION
ANDA040547
TYPE
ANDA
ORIGINAL APPROVAL
2005-02-18
LATEST ACTION
2019-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
METHIMAZOLEPrescription
METHIMAZOLE 10MG · TABLET · ORAL
METHIMAZOLEDiscontinued
METHIMAZOLE 20MG · TABLET · ORAL
METHIMAZOLEPrescription
METHIMAZOLE 5MG · TABLET · ORAL
METHIMAZOLEDiscontinued
METHIMAZOLE 20MG · TABLET · ORAL
Approval history
2019-01-18Labeling · Supplement 11 · standardAP
2016-01-15Labeling · Supplement 9 · standardAP
2005-02-18OriginalAP
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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