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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212018
Company: JANSSEN BIOTECH

Products on NDA 212018

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BALVERSA	ERDAFITINIB	3MG	TABLET;ORAL	Prescription	None	Yes	No
BALVERSA	ERDAFITINIB	4MG	TABLET;ORAL	Prescription	None	Yes	No
BALVERSA	ERDAFITINIB	5MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212018

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212018s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212018Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212018Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/09/2024	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212018Orig1s010ltr.pdf
01/19/2024	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212018Orig1s007; s008; s009ltr.pdf
01/19/2024	SUPPL-8	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212018Orig1s007; s008; s009ltr.pdf
01/19/2024	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212018Orig1s007; s008; s009ltr.pdf
03/20/2023	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212018s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212018Orig1s005ltr.pdf
01/11/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212018s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212018Orig1s004ltr.pdf
04/27/2022	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212018s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212018Orig1s002s003ltr.pdf
04/27/2022	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212018s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212018Orig1s002s003ltr.pdf
04/02/2020	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212018s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212018Orig1s001ltr.pdf

Labels for NDA 212018

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/09/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s010lbl.pdf
01/19/2024	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf
01/19/2024	SUPPL-8	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf
01/19/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf
03/20/2023	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212018s005lbl.pdf
01/11/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212018s004lbl.pdf
04/27/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212018s002s003lbl.pdf
04/27/2022	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212018s002s003lbl.pdf
04/27/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212018s002s003lbl.pdf
04/02/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212018s001lbl.pdf
04/12/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212018s000lbl.pdf

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