APPLICATION
ANDA203536
TYPE
ANDA
ORIGINAL APPROVAL
2015-01-05
LATEST ACTION
2022-08-17
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
2022-08-17Manufacturing (CMC) · Supplement 16 · unknownAP
2020-05-05Labeling · Supplement 4 · standardAP
2020-05-05Labeling · Supplement 2 · standardAP
2020-05-05Labeling · Supplement 7 · standardAP
2015-01-05UNKNOWN · 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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