Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022217
Company: NOVARTIS
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
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
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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