FDA ANDA · ANDA204011
VALSARTAN
Sponsor: AMNEAL PHARMS
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APPLICATION
ANDA204011
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-11
LATEST ACTION
2026-10-06
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
2026-10-06Labeling · Supplement 22 · standardAP
2022-07-21Labeling · Supplement 17 · standardAP
2022-07-21Labeling · Supplement 15 · standardAP
2019-09-20Labeling · Supplement 2 · standardAP
2019-09-20Labeling · Supplement 1 · standardAP
2016-01-11UNKNOWN · OriginalAP
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