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FDA ANDA · ANDA090245

AMLODIPINE AND VALSARTAN

Sponsor: LUPIN

APPLICATION
ANDA090245
TYPE
ANDA
ORIGINAL APPROVAL
2015-03-30
LATEST ACTION
2023-03-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2023-03-22Labeling · Supplement 12 · standardAP
2019-08-19Labeling · Supplement 8 · standardAP
2015-12-21Labeling · Supplement 1 · standardAP
2015-03-30OriginalAP
VIEW ON DRUGS@FDA ↗

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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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