← FDA DRUG APPROVALS

FDA NDA · NDA022314

EXFORGE HCT

amlodipine valsartan and hydrochlorothiazide

Sponsor: NOVARTIS

APPLICATION
NDA022314
TYPE
NDA
ORIGINAL APPROVAL
2009-04-30
LATEST ACTION
2022-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EXFORGE HCT · ReferencePrescription
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL
EXFORGE HCT · ReferencePrescription
AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 320MG · TABLET · ORAL
EXFORGE HCT · ReferencePrescription
AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 160MG · TABLET · ORAL
EXFORGE HCT · ReferencePrescription
AMLODIPINE BESYLATE EQ 5MG BASE, HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 160MG · TABLET · ORAL
EXFORGE HCT · ReferencePrescription
AMLODIPINE BESYLATE EQ 10MG BASE, HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL

Approval history

2022-09-26Manufacturing (CMC) · Supplement 38 — Letter ↗AP
2021-02-22Labeling · Supplement 36 · standard — Letter ↗AP
2020-08-20Labeling · Supplement 35 · standard — Label ↗AP
2019-06-12Labeling · Supplement 27 · standard — Letter ↗AP
2016-02-12Manufacturing (CMC) · Supplement 22 · standardAP
2015-07-28Labeling · Supplement 20 · standard — Letter ↗AP
2014-09-24Labeling · Supplement 19 · standard — Label ↗AP
2014-06-09Manufacturing (CMC) · Supplement 17 · standard — Label ↗AP
2014-03-17Labeling · Supplement 15 · standard — Label ↗AP
2014-03-17Labeling · Supplement 16 · standard — Label ↗AP
2012-11-28Labeling · Supplement 14 · standard — Label ↗AP
2012-09-28Labeling · Supplement 13 · unknown — Label ↗AP
2012-02-16Labeling · Supplement 9 · unknown — Label ↗AP
2012-01-18Labeling · Supplement 12 · unknown — Letter ↗AP
2011-12-07Labeling · Supplement 7 · unknown — Label ↗AP
2011-10-31Labeling · Supplement 11 · unknown — Label ↗AP
2011-06-03Labeling · Supplement 5 · unknown — Label ↗AP
2009-04-30Type 4 - New Combination · Original · standard — Review ↗AP
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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