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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203415
Company: ASTELLAS

Summary Review

Products on NDA 203415

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XTANDI	ENZALUTAMIDE	40MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203415

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

Labels for NDA 203415

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

Therapeutic Equivalents for NDA 203415

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

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