APPLICATION
ANDA204164
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-22
LATEST ACTION
2025-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TELMISARTANPrescription
TELMISARTAN 40MG · TABLET · ORAL
TELMISARTANPrescription
TELMISARTAN 80MG · TABLET · ORAL
TELMISARTANPrescription
TELMISARTAN 20MG · TABLET · ORAL
Approval history
2025-03-12Labeling · Supplement 8 · standardAP
2019-11-04Labeling · Supplement 2 · standardAP
2016-08-22UNKNOWN · 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.