← FDA DRUG APPROVALS

FDA NDA · NDA021990

EXFORGE

amlodipine besylate and valsartan

Sponsor: NOVARTIS

APPLICATION
NDA021990
TYPE
NDA
ORIGINAL APPROVAL
2007-06-20
LATEST ACTION
2021-04-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2021-04-07Labeling · Supplement 41 · standard — Letter ↗AP
2019-06-12Labeling · Supplement 33 · standard — Letter ↗AP
2016-02-12Manufacturing (CMC) · Supplement 28 · standardAP
2015-12-21Manufacturing (CMC) · Supplement 27 · standardAP
2015-07-28Labeling · Supplement 26 · standard — Letter ↗AP
2015-05-22Manufacturing (CMC) · Supplement 25 · standardAP
2014-09-24Labeling · Supplement 24 · standard — Letter ↗AP
2014-06-09Manufacturing (CMC) · Supplement 22 · standardAP
2014-03-17Labeling · Supplement 20 · standard — Letter ↗AP
2014-03-17Labeling · Supplement 21 · standard — Label ↗AP
2012-11-28Labeling · Supplement 19 · standard — Label ↗AP
2012-09-28Labeling · Supplement 18 · unknown — Label ↗AP
2012-01-18Labeling · Supplement 17 · unknown — Label ↗AP
2011-12-07Labeling · Supplement 14 · unknown — Label ↗AP
2011-10-31Labeling · Supplement 16 · unknown — Label ↗AP
2011-05-31Labeling · Supplement 13 · unknown — Label ↗AP
2010-03-30Labeling · Supplement 7 · standard — Label ↗AP
2008-07-23Efficacy · Supplement 3 · standard — Label ↗AP
2007-06-20Type 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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