← FDA DRUG APPROVALS

FDA ANDA · ANDA206180

AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA206180
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-19
LATEST ACTION
2023-09-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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
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

Approval history

2023-09-29Labeling · Supplement 10 · standardAP
2022-03-11Labeling · Supplement 8 · standardAP
2022-03-11Labeling · Supplement 9 · standardAP
2020-03-16Labeling · Supplement 5 · standardAP
2017-12-19UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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