APPLICATION
ANDA205347
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-09
LATEST ACTION
2019-09-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALSARTANPrescription
VALSARTAN 40MG · TABLET · ORAL
VALSARTANPrescription
VALSARTAN 320MG · TABLET · ORAL
VALSARTANPrescription
VALSARTAN 80MG · TABLET · ORAL
VALSARTANPrescription
VALSARTAN 160MG · TABLET · ORAL
Approval history
2019-09-03Labeling · Supplement 1 · standardAP
2018-04-09UNKNOWN · Original · standardAP
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.