← FDA DRUG APPROVALS

FDA ANDA · ANDA201087

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

amlodipine besylate valsartan hydrochlorothiazide

Sponsor: STRIDES PHARMA INTL

APPLICATION

ANDA201087

TYPE

ANDA

ORIGINAL APPROVAL

2015-06-01

LATEST ACTION

2021-04-05

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription

AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 160MG · TABLET · ORAL

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription

AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription

AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription

AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 320MG · TABLET · ORAL

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription

AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 160MG · TABLET · ORAL

Approval history

2021-04-05Labeling · Supplement 7 · standardAP

2021-04-05Labeling · Supplement 1 · standardAP

2021-04-05Labeling · Supplement 6 · standardAP

2015-06-01Not Applicable · OriginalAP

VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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