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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210951
Company: JANSSEN BIOTECH

Products on NDA 210951

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERLEADA	APALUTAMIDE	60MG	TABLET;ORAL	Prescription	None	Yes	No
ERLEADA	APALUTAMIDE	240MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210951

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/14/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210951s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210951Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/Erleada_210951_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2024	SUPPL-17	Manufacturing (CMC)-Manufacturing Process	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210951s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210951Orig1s017ltr.pdf
08/02/2024	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210951s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210951Orig1s016ltr.pdf
12/19/2023	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210951s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210951Orig1s014ltr.pdf
02/17/2023	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210951Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210951Orig1s011ltr.pdf
11/08/2022	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210951s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210951Orig1s009; s010ltr.pdf
11/08/2022	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210951s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210951Orig1s009; s010ltr.pdf
04/26/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210951s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210951Orig1s007ltr.pdf
09/07/2021	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210951s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210951Orig1s006ltr.pdf
07/14/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210951s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210951Orig1s005ltr.pdf
11/20/2020	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210951s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210951Orig1s004ltr.pdf
09/01/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210951s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210951Orig1s003ltr.pdf
07/10/2020	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210951s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210951Orig1s002ltr.pdf
09/17/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210951s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210951Orig1s001ltr.pdf

Labels for NDA 210951

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2024	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210951s016lbl.pdf
07/09/2024	SUPPL-17	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210951s017lbl.pdf
12/19/2023	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210951s014lbl.pdf
02/17/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210951Orig1s011lbl.pdf
11/08/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210951s009s010lbl.pdf
11/08/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210951s009s010lbl.pdf
04/26/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210951s007lbl.pdf
09/07/2021	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210951s006lbl.pdf
07/14/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210951s005lbl.pdf
11/20/2020	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210951s004lbl.pdf
09/01/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210951s003lbl.pdf
07/10/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210951s002lbl.pdf
09/17/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210951s001lbl.pdf
02/14/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210951s000lbl.pdf

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