APPLICATION
ANDA202829
TYPE
ANDA
ORIGINAL APPROVAL
2015-03-30
LATEST ACTION
2024-02-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMLODIPINE BESYLATE AND VALSARTANPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, VALSARTAN 320MG · TABLET · ORAL
AMLODIPINE BESYLATE AND VALSARTANPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, VALSARTAN 160MG · TABLET · ORAL
AMLODIPINE BESYLATE AND VALSARTANPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, VALSARTAN 320MG · TABLET · ORAL
AMLODIPINE BESYLATE AND VALSARTANPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, VALSARTAN 160MG · TABLET · ORAL
Approval history
2024-02-20Labeling · Supplement 3 · standardAP
2024-02-20Labeling · Supplement 2 · standardAP
2015-03-30UNKNOWN · 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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