APPLICATION
ANDA201189
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-17
LATEST ACTION
2019-10-28
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
2019-10-28Labeling · Supplement 5 · standardAP
2019-10-28Labeling · Supplement 7 · standardAP
2014-01-22Not Applicable · OriginalAP
2013-08-26Labeling · Supplement 1 · standardAP
2013-07-17Not Applicable · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.