APPLICATION
ANDA077571
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-11
LATEST ACTION
2019-10-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, None (Tentative Approval)
Products
REPAGLINIDEDiscontinued
REPAGLINIDE 2MG · TABLET · ORAL
REPAGLINIDENone (Tentative Approval)
REPAGLINIDE 0.5MG · TABLET · ORAL
REPAGLINIDEDiscontinued
REPAGLINIDE 1MG · TABLET · ORAL
Approval history
2019-10-01Labeling · Supplement 8 · standardAP
2019-10-01Labeling · Supplement 12 · standardAP
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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