Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021882
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXJADE | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| EXJADE | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| EXJADE | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-37 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021882Orig1s037lbl.pdf | |
| 07/23/2020 | SUPPL-33 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021882s033lbl.pdf | |
| 07/24/2019 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021882s030lbl.pdf | |
| 05/24/2019 | SUPPL-31 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021882s031lbl.pdf | |
| 12/12/2018 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s028s029lbl.pdf | |
| 12/12/2018 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s028s029lbl.pdf | |
| 05/11/2018 | SUPPL-25 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s025lbl.pdf | |
| 02/16/2018 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s026lbl.pdf | |
| 08/12/2016 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021882s024lbl.pdf | |
| 07/23/2015 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021882s021lbl.pdf | |
| 10/21/2013 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s019lbl.pdf | |
| 05/29/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s017lbl.pdf | |
| 01/23/2013 | SUPPL-15 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s015lbl.pdf | |
| 09/14/2012 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021882s014lbl.pdf | |
| 08/10/2011 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s012lbl.pdf | |
| 04/11/2011 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s011lbl.pdf | |
| 01/28/2010 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021882s010lbl.pdf | |
| 04/22/2009 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021882s006lbl.pdf | |
| 10/02/2008 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021882s004lbl.pdf | |
| 12/21/2007 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s003lbl.pdf | |
| 04/20/2007 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s002lbl.pdf | |
| 11/02/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021882lbl.pdf |