APPLICATION
ANDA203311
TYPE
ANDA
ORIGINAL APPROVAL
2015-01-05
LATEST ACTION
2021-12-07
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
2021-12-07Labeling · Supplement 15 · standardAP
2021-12-07Labeling · Supplement 16 · standardAP
2019-11-06Labeling · Supplement 5 · standardAP
2019-11-06Labeling · Supplement 3 · standardAP
2019-11-06Labeling · Supplement 9 · 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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