Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 212726
Company: GENENTECH INC

Products on NDA 212726

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROZLYTREK	ENTRECTINIB	100MG	CAPSULE;ORAL	Prescription	TBD	TBD	No
ROZLYTREK	ENTRECTINIB	200MG	CAPSULE;ORAL	Prescription	TBD	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212726

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/15/2019	ORIG-1	Approval		PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212726s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212726Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212725Orig1s000,%20212726Orig1s000TOC.html

Labels for NDA 212726

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/15/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212726s000lbl.pdf

Therapeutic Equivalents for NDA 212726

ROZLYTREK

There are no Therapeutic Equivalents.