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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022217
Company: NOVARTIS

Summary Review

Products on NDA 022217

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALTURNA	ALISKIREN HEMIFUMARATE; VALSARTAN	EQ 150MG BASE;160MG	TABLET;ORAL	Discontinued	None	No	No
VALTURNA	ALISKIREN HEMIFUMARATE; VALSARTAN	EQ 300MG BASE;320MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022217

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/2009	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022217lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022217s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022217_valturna_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022217s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2012	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022217s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022217s020ltr.pdf
02/02/2012	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022217s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022217s017ltr.pdf
01/26/2012	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022217s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022217s016ltr.pdf
10/13/2011	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022217s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022217s014ltr.pdf
05/04/2011	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022217s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022217s013ltr.pdf
02/10/2011	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022217s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022217s007ltr.pdf
08/04/2010	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022217s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022217s005ltr.pdf

Labels for NDA 022217

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2012	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022217s020lbl.pdf
02/02/2012	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022217s017lbl.pdf
01/26/2012	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022217s016lbl.pdf
10/13/2011	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022217s014lbl.pdf
05/04/2011	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022217s013lbl.pdf
02/10/2011	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022217s007lbl.pdf
08/04/2010	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022217s005lbl.pdf
09/16/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022217lbl.pdf

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