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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/02/2005 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021882lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021882ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021882_s000_ExjadeTOC.cfm |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021882Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021882Orig1s037ltr.pdf | |
| 07/23/2020 | SUPPL-33 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021882s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021882Orig1s033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021882Orig1s033ltr.pdf | |
| 05/24/2019 | SUPPL-31 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021882s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021882Orig1s031ltr.pdf | |
| 07/24/2019 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021882s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021882Orig1s030ltredt.pdf | |
| 12/12/2018 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021882Orig1s028, 021882Orig1s029ltr.pdf | |
| 12/12/2018 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021882Orig1s028, 021882Orig1s029ltr.pdf | |
| 02/16/2018 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021882Orig1s026ltr.pdf | |
| 05/11/2018 | SUPPL-25 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021882Orig1s025ltr.pdf | |
| 08/12/2016 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021882s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021882Orig1s024ltr.pdf | |
| 07/23/2015 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021882s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021882Orig1s021ltr.pdf | |
| 10/21/2013 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s019ltr.pdf | |
| 11/01/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/2013 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s017ltr.pdf | |
| 01/23/2013 | SUPPL-16 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s015,s016ltr.pdf |
| 01/23/2013 | SUPPL-15 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s015,s016ltr.pdf | |
| 09/14/2012 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021882s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021882Orig1s014ltr.pdf | |
| 08/10/2011 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021882s012ltr.pdf | |
| 04/11/2011 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021882s011ltr.pdf | |
| 01/28/2010 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021882s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021882s010ltr.pdf | |
| 03/05/2009 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021882s007ltr.pdf |
| 04/22/2009 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021882s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021882s006ltr.pdf | |
| 10/02/2008 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021882s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021882s004ltr.pdf | |
| 12/21/2007 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021882s003ltr.pdf | |
| 04/20/2007 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021882s002lltr.pdf |
| 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 |
EXJADE
TABLET, FOR SUSPENSION;ORAL; 125MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 203560 | ACTAVIS ELIZABETH |
| DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210060 | ALEMBIC |
| DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210519 | ALKEM LABS LTD |
| DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210920 | BIONPHARMA |
| DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209433 | GLENMARK SPECLT |
| DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209878 | MSN |
| DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209782 | SUN PHARM |
| DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 207124 | TEVA PHARMS USA |
| DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209426 | TORRENT |
| EXJADE | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 021882 | NOVARTIS |
TABLET, FOR SUSPENSION;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 203560 | ACTAVIS ELIZABETH |
| DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210060 | ALEMBIC |
| DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210519 | ALKEM LABS LTD |
| DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210920 | BIONPHARMA |
| DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209433 | GLENMARK SPECLT |
| DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209878 | MSN |
| DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209782 | SUN PHARM |
| DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 207124 | TEVA PHARMS USA |
| DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209426 | TORRENT |
| EXJADE | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 021882 | NOVARTIS |
TABLET, FOR SUSPENSION;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 203560 | ACTAVIS ELIZABETH |
| DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210060 | ALEMBIC |
| DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210519 | ALKEM LABS LTD |
| DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210920 | BIONPHARMA |
| DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209433 | GLENMARK SPECLT |
| DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209878 | MSN |
| DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209782 | SUN PHARM |
| DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 207124 | TEVA PHARMS USA |
| DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209426 | TORRENT |
| EXJADE | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 021882 | NOVARTIS |