APPLICATION
ANDA202696
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-16
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALSARTANPrescription
VALSARTAN 320MG · TABLET · ORAL
VALSARTANPrescription
VALSARTAN 80MG · TABLET · ORAL
VALSARTANPrescription
VALSARTAN 160MG · TABLET · ORAL
VALSARTANPrescription
VALSARTAN 40MG · TABLET · ORAL
Approval history
2023-06-07Labeling · Supplement 25 · standardAP
2021-12-06Labeling · Supplement 23 · standardAP
2020-04-08Labeling · Supplement 2 · standardAP
2019-09-04Labeling · Supplement 13 · standardAP
2016-09-16UNKNOWN · 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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