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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213736
Company: INCYTE CORP

Products on NDA 213736

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PEMAZYRE	PEMIGATINIB	4.5MG	TABLET;ORAL	Prescription	None	Yes	No
PEMAZYRE	PEMIGATINIB	9MG	TABLET;ORAL	Prescription	None	Yes	No
PEMAZYRE	PEMIGATINIB	13.5MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213736

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213736Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213736Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2022	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213736Orig1s002ltr.pdf
02/23/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213736s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213736Orig1s001ltr.pdf

Labels for NDA 213736

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2022	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf
02/23/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213736s001lbl.pdf
04/17/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf

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