← FDA DRUG APPROVALS
FDA ANDA · ANDA200435
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Sponsor: TEVA PHARMS
APPLICATION
ANDA200435
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-25
LATEST ACTION
2015-12-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
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 320MG · TABLET · ORAL
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · 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 10MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL
Approval history
2015-12-11Labeling · Supplement 4 · standardAP
2015-01-02Labeling · Supplement 3 · standardAP
2015-01-02Labeling · Supplement 1 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.