Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207968
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
JADENU SPRINKLE | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | AB | Yes | No |
JADENU SPRINKLE | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | AB | Yes | No |
JADENU SPRINKLE | DEFERASIROX | 360MG | GRANULE;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 |
---|---|---|---|---|---|---|---|
05/18/2017 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207968s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207968Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207968Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207968Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/23/2020 | SUPPL-9 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207968s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207968Orig1s009ltr.pdf | |
05/24/2019 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s014,207968s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206910Orig1s014, 207968Orig1s008ltr.pdf | |
07/25/2019 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207968s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207968Orig1s007ltr.pdf | |
12/12/2018 | SUPPL-6 | Labeling-Package Insert |
Label
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s004, 207968Orig1s006ltr.pdf | |
08/03/2018 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s010,207968s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s10,207968Orig1s005Ltr.pdf | |
12/12/2018 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s004, 207968Orig1s006ltr.pdf | |
02/16/2018 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s002ltr.pdf | |
05/11/2018 | SUPPL-1 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/23/2020 | SUPPL-9 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207968s009lbl.pdf | |
07/25/2019 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207968s007lbl.pdf | |
05/24/2019 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s014,207968s008lbl.pdf | |
12/12/2018 | SUPPL-6 | Labeling-Package Insert | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl | ||
12/12/2018 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl | ||
08/03/2018 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s010,207968s005lbl.pdf | |
05/11/2018 | SUPPL-1 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s001lbl.pdf | |
02/16/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s002lbl.pdf | |
05/18/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207968s000lbl.pdf |
JADENU SPRINKLE
GRANULE;ORAL; 90MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 213374 | ALKEM LABS LTD |
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 216229 | ANNORA PHARMA |
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 214559 | AUCTA |
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 215026 | CIPLA |
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 214650 | MSN |
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 214180 | TEVA PHARMS USA |
JADENU SPRINKLE | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | Yes | AB | 207968 | NOVARTIS |
GRANULE;ORAL; 180MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 213374 | ALKEM LABS LTD |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 216229 | ANNORA PHARMA |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 214559 | AUCTA |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 215026 | CIPLA |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 214650 | MSN |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 214180 | TEVA PHARMS USA |
JADENU SPRINKLE | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | Yes | AB | 207968 | NOVARTIS |
GRANULE;ORAL; 360MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 213374 | ALKEM LABS LTD |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 216229 | ANNORA PHARMA |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 214559 | AUCTA |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 215026 | CIPLA |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 214650 | MSN |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 214180 | TEVA PHARMS USA |
JADENU SPRINKLE | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | Yes | AB | 207968 | NOVARTIS |