Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021990
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET;ORAL | Prescription | AB | Yes | No |
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET;ORAL | Prescription | AB | Yes | No |
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/07/2021 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021990s041lbl.pdf | |
| 06/12/2019 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021990s033lbl.pdf | |
| 07/28/2015 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021990s026lbl.pdf | |
| 09/24/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021990s024lbl.pdf | |
| 03/17/2014 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021990s020s021lbl.pdf | |
| 11/28/2012 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s019lbl.pdf | |
| 09/28/2012 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s018lbl.pdf | |
| 01/18/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s017lbl.pdf | |
| 12/07/2011 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s014lbl.pdf | |
| 10/31/2011 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s016lbl.pdf | |
| 05/31/2011 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s013lbl.pdf | |
| 03/30/2010 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021990s007lbl.pdf | |
| 07/23/2008 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021990s003lbl.pdf | |
| 06/20/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021990lbl.pdf |