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FDA ANDA · ANDA077274

GLIMEPIRIDE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA077274
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-06
LATEST ACTION
2019-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GLIMEPIRIDEDiscontinued
GLIMEPIRIDE 2MG · TABLET · ORAL
GLIMEPIRIDEDiscontinued
GLIMEPIRIDE 4MG · TABLET · ORAL
GLIMEPIRIDEDiscontinued
GLIMEPIRIDE 1MG · TABLET · ORAL

Approval history

2019-05-31Labeling · Supplement 9 · standardAP
2017-04-17Labeling · Supplement 8 · standardAP
2010-11-18Labeling · Supplement 7AP
2010-06-23Labeling · Supplement 6AP
2009-09-21Labeling · Supplement 5AP
2007-10-01Labeling · Supplement 2AP
2006-08-15Labeling · Supplement 1AP
2005-10-06OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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