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FDA ANDA · ANDA040350

METHIMAZOLE

Sponsor: MYLAN

APPLICATION
ANDA040350
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-29
LATEST ACTION
2021-10-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

METHIMAZOLEDiscontinued
METHIMAZOLE 20MG · TABLET · ORAL
METHIMAZOLEPrescription
METHIMAZOLE 5MG · TABLET · ORAL
METHIMAZOLEPrescription
METHIMAZOLE 10MG · TABLET · ORAL

Approval history

2021-10-20Labeling · Supplement 24 · standardAP
2019-01-18Labeling · Supplement 23 · standardAP
2016-01-15Labeling · Supplement 19 · standardAP
2012-07-11Labeling · Supplement 16 — Label ↗AP
2001-09-28Manufacturing (CMC) · Supplement 6AP
2001-07-10Manufacturing (CMC) · Supplement 5AP
2001-06-07Labeling · Supplement 4AP
2001-06-07Manufacturing (CMC) · Supplement 2 — Review ↗AP
2001-06-07Manufacturing (CMC) · Supplement 3 — Review ↗AP
2001-06-07Manufacturing (CMC) · Supplement 1 — Review ↗AP
2000-03-29Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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