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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217242
Company: ARCUTIS

Products on NDA 217242

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZORYVE	ROFLUMILAST	0.3%	FOAM;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217242

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2023	ORIG-1	Approval	Type 3 - New Dosage Form and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217242s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217242Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217242Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217242s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217242Orig1s005ltr.pdf
06/12/2024	SUPPL-2	Manufacturing (CMC)-Manufacturing Process	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217242Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217242Orig1s002ltr.pdf

Labels for NDA 217242

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217242s005lbl.pdf
06/12/2024	SUPPL-2	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217242Orig1s002lbl.pdf
12/15/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217242s000lbl.pdf

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