Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213498
Company: JANSSEN PHARMS

• Medication Guide

Products on NDA 213498

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PONVORY	PONESIMOD	2MG	TABLET;ORAL	Prescription	None	Yes	Yes
PONVORY	PONESIMOD	3MG	TABLET;ORAL	Prescription	None	Yes	No
PONVORY	PONESIMOD	4MG	TABLET;ORAL	Prescription	None	Yes	No
PONVORY	PONESIMOD	5MG	TABLET;ORAL	Prescription	None	Yes	No
PONVORY	PONESIMOD	6MG	TABLET;ORAL	Prescription	None	Yes	No
PONVORY	PONESIMOD	7MG	TABLET;ORAL	Prescription	None	Yes	No
PONVORY	PONESIMOD	8MG	TABLET;ORAL	Prescription	None	Yes	No
PONVORY	PONESIMOD	9MG	TABLET;ORAL	Prescription	None	Yes	No
PONVORY	PONESIMOD	10MG	TABLET;ORAL	Prescription	None	Yes	No
PONVORY	PONESIMOD	20MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213498

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213498Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213498Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213498s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213498Orig1s004ltr.pdf
10/28/2021	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213498Orig1s001ltr.pdf

Labels for NDA 213498

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213498s004lbl.pdf
10/28/2021	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.pdf
10/28/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.pdf
03/18/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s000lbl.pdf