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FDA ANDA · ANDA078952

GLIMEPIRIDE

Sponsor: HIKMA PHARMS

APPLICATION
ANDA078952
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-01
LATEST ACTION
2013-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2013-08-01OriginalAP
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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