APPLICATION
ANDA219062
TYPE
ANDA
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
AZILSARTAN MEDOXOMILNone (Tentative Approval)
AZILSARTAN MEDOXOMIL 20MG · TABLET
AZILSARTAN MEDOXOMILNone (Tentative Approval)
AZILSARTAN MEDOXOMIL 80MG · TABLET
AZILSARTAN MEDOXOMILNone (Tentative Approval)
AZILSARTAN MEDOXOMIL 40MG · TABLET
Approval history
2025-03-19UNKNOWN · Original · standardTA
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.