Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218550
Company: GENENTECH INC

Products on NDA 218550

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROZLYTREK	ENTRECTINIB	50MG/PACKET	PELLETS;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218550

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/2023	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218550Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/218550Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2023	SUPPL-1		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218550Orig1s000lbl.pdf

Labels for NDA 218550

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2023	SUPPL-1	Type 3 - New Dosage Form	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218550Orig1s000lbl.pdf