Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217171
Company: APELLIS PHARMS

Products on NDA 217171

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYFOVRE	PEGCETACOPLAN	15MG/0.1ML (15MG/0.1ML)	SOLUTION;INTRAVITREAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217171

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2023	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217171s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217171Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217171Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2023	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217171s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217171Orig1s001ltr.pdf

Labels for NDA 217171

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2023	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217171s001lbl.pdf
02/17/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217171s000lbl.pdf