Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203415
Company: ASTELLAS
Company: ASTELLAS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XTANDI | ENZALUTAMIDE | 40MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
08/31/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203415Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203415_xtandi_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203415Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/16/2023 | SUPPL-22 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213674s010,203415s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213674Orig1s010; 203415Orig1s022ltr.pdf | |
09/09/2022 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s019,213674s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203415Orig1s019; 213674Orig1s006ltr.pdf | |
01/13/2022 | SUPPL-18 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s018,213674s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203415Orig1s018; 213674Orig1s005ltr.pdf | |
10/23/2020 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203415s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203415Orig1s016ltr.pdf | |
12/16/2019 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203415s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203415Orig1s015ltr.pdf | |
07/13/2018 | SUPPL-14 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203415Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203415Orig1s014ltr.pdf | |
07/24/2017 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203415s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203415Orig1s011ltr.pdf | |
07/14/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/20/2016 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203415s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203415Orig1s009ltr.pdf | |
11/06/2015 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/01/2015 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s007ltr.pdf | |
08/05/2015 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s006ltr.pdf | |
07/21/2015 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s005ltr.pdf | |
09/10/2014 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203415s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203415Orig1s003ltr.pdf | |
05/23/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/19/2013 | SUPPL-1 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203415s001lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/16/2023 | SUPPL-22 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213674s010,203415s022lbl.pdf | |
09/09/2022 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s019,213674s006lbl.pdf | |
01/13/2022 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s018,213674s005lbl.pdf | |
01/13/2022 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s018,213674s005lbl.pdf | |
10/23/2020 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203415s016lbl.pdf | |
12/16/2019 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203415s015lbl.pdf | |
07/13/2018 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203415Orig1s014lbl.pdf | |
07/24/2017 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203415s011lbl.pdf | |
10/20/2016 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203415s009lbl.pdf | |
10/01/2015 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s007lbl.pdf | |
08/05/2015 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s006lbl.pdf | |
07/21/2015 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s005lbl.pdf | |
09/10/2014 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203415s003lbl.pdf | |
03/19/2013 | SUPPL-1 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203415s001lbl.pdf |
08/31/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf |
XTANDI
CAPSULE;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
XTANDI | ENZALUTAMIDE | 40MG | CAPSULE;ORAL | Prescription | Yes | AB | 203415 | ASTELLAS |