APPLICATION
ANDA202375
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-24
LATEST ACTION
2022-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OLMESARTAN MEDOXOMILDiscontinued
OLMESARTAN MEDOXOMIL 20MG · TABLET · ORAL
OLMESARTAN MEDOXOMILDiscontinued
OLMESARTAN MEDOXOMIL 40MG · TABLET · ORAL
OLMESARTAN MEDOXOMILDiscontinued
OLMESARTAN MEDOXOMIL 5MG · TABLET · ORAL
Approval history
2022-08-29Labeling · Supplement 7 · standardAP
2017-04-24UNKNOWN · 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.