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 |
| 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 |