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FDA ANDA · ANDA202377

AMLODIPINE BESYLATE AND VALSARTAN

Sponsor: TORRENT

APPLICATION
ANDA202377
TYPE
ANDA
ORIGINAL APPROVAL
2015-03-30
LATEST ACTION
2025-10-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMLODIPINE BESYLATE AND VALSARTANDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, VALSARTAN 160MG · TABLET · ORAL
AMLODIPINE BESYLATE AND VALSARTANDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, VALSARTAN 160MG · TABLET · ORAL
AMLODIPINE BESYLATE AND VALSARTANDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, VALSARTAN 320MG · TABLET · ORAL
AMLODIPINE BESYLATE AND VALSARTANDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, VALSARTAN 320MG · TABLET · ORAL

Approval history

2025-10-15Labeling · Supplement 6 · standardAP
2025-10-15Labeling · Supplement 5 · standardAP
2015-03-30UNKNOWN · OriginalAP
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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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