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FDA ANDA · ANDA040320

TAPAZOLE

Sponsor: KING PHARMS LLC

APPLICATION
ANDA040320
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-31
LATEST ACTION
2024-06-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TAPAZOLEDiscontinued
METHIMAZOLE 5MG · TABLET · ORAL
TAPAZOLEDiscontinued
METHIMAZOLE 10MG · TABLET · ORAL

Approval history

2024-06-14Labeling · Supplement 13 · standardAP
2019-01-18Labeling · Supplement 12 · standardAP
2019-01-04Labeling · Supplement 8 · standardAP
2016-01-15Labeling · Supplement 11 · standardAP
2012-07-16Labeling · Supplement 5 — Label ↗AP
2004-08-06Labeling · Supplement 1AP
2000-03-31Original — Letter ↗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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