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FDA ANDA · ANDA200797

AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Sponsor: LUPIN

APPLICATION
ANDA200797
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-03
LATEST ACTION
2020-03-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 320MG · TABLET · ORAL
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 160MG · TABLET · ORAL
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 160MG · TABLET · ORAL
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL

Approval history

2020-03-16Labeling · Supplement 4 · standardAP
2015-12-21Labeling · Supplement 1 · standardAP
2015-06-03Not Applicable · OriginalAP
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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