Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022217
Company: NOVARTIS
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 |