APPLICATION
ANDA204821
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-09
LATEST ACTION
2025-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALSARTANPrescription
VALSARTAN 160MG · TABLET · ORAL
VALSARTANPrescription
VALSARTAN 40MG · TABLET · ORAL
VALSARTANPrescription
VALSARTAN 320MG · TABLET · ORAL
VALSARTANPrescription
VALSARTAN 80MG · TABLET · ORAL
Approval history
2025-05-08Labeling · Supplement 7 · standardAP
2025-05-08Labeling · Supplement 8 · standardAP
2020-07-10Labeling · Supplement 3 · standardAP
2020-07-10Labeling · Supplement 6 · standardAP
2016-03-24Labeling · Supplement 1 · standardAP
2015-06-09UNKNOWN · 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.
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