APPLICATION
ANDA202012
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-16
LATEST ACTION
2015-11-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EPROSARTAN MESYLATEDiscontinued
EPROSARTAN MESYLATE EQ 400MG BASE · TABLET · ORAL
EPROSARTAN MESYLATEDiscontinued
EPROSARTAN MESYLATE EQ 600MG BASE · TABLET · ORAL
Approval history
2015-11-20Labeling · Supplement 3 · standardAP
2015-11-20Labeling · Supplement 4 · standardAP
2013-09-20Labeling · Supplement 1AP
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.