FDA Approval for OPZELURA issued to INCYTE CORP

9/22/21 11:16:23 AM ET

$INCY

Biotechnology: Commercial Physical & Biological Resarch

Health Care

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New Drug Application (NDA): 215309
Company: INCYTE CORP

Products on NDA 215309

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OPZELURA	RUXOLITINIB	1ML	CREAM;TOPICAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215309

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2021	ORIG-1	Approval		PRIORITY	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215309Orig1s000ltr.pdf

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FDA Approval for OPZELURA issued to INCYTE CORP

Products on NDA 215309

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215309

Original Approvals or Tentative Approvals

Chat with this insight

Recent Analyst Ratings for $INCY

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SEC Form 10-Q filed by Incyte Corp.

Incyte Corp. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

SEC Form 10-Q filed by Incyte Corp.

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