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FDA ANDA · ANDA090252

REPAGLINIDE

Sponsor: QUAGEN

APPLICATION
ANDA090252
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-23
LATEST ACTION
2019-10-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

REPAGLINIDEDiscontinued
REPAGLINIDE 1MG · TABLET · ORAL
REPAGLINIDEDiscontinued
REPAGLINIDE 2MG · TABLET · ORAL
REPAGLINIDEDiscontinued
REPAGLINIDE 0.5MG · TABLET · ORAL

Approval history

2019-10-03Labeling · Supplement 9 · standardAP
2019-10-03Labeling · Supplement 5 · standardAP
2015-07-07Labeling · Supplement 1 · standardAP
2014-01-22OriginalAP
2013-08-23OriginalAP
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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