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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022314
Company: NOVARTIS

Summary Review

Products on NDA 22314

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;12.5MG;160MG	TABLET;ORAL	Prescription	AB	Yes	No
EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;25MG;160MG	TABLET;ORAL	Prescription	AB	Yes	No
EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;12.5MG;160MG	TABLET;ORAL	Prescription	AB	Yes	No
EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;160MG	TABLET;ORAL	Prescription	AB	Yes	No
EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;320MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 022314

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2022	SUPPL-38	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022314Orig1s038lbl.pdf
02/22/2021	SUPPL-36	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022314Orig1s036lbl.pdf
08/20/2020	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022314s035lbl.pdf
06/12/2019	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022314s027lbl.pdf
07/28/2015	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022314s020lbl.pdf
09/24/2014	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s019lbl.pdf
06/09/2014	SUPPL-17	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s017lbl.pdf
03/17/2014	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s015s016lbl.pdf
03/17/2014	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s015s016lbl.pdf
11/28/2012	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s014lbl.pdf
09/28/2012	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s013lbl.pdf
02/16/2012	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s009lbl.pdf
12/07/2011	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s007lbl.pdf
10/31/2011	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s011lbl.pdf
06/03/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s005lbl.pdf
04/30/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022314lbl.pdf

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