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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212725
Company: GENENTECH INC

Products on NDA 212725

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROZLYTREK	ENTRECTINIB	100MG	CAPSULE;ORAL	Prescription	None	Yes	No
ROZLYTREK	ENTRECTINIB	200MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212725

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	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212725s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212725Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212725Orig1s000, 212726Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2024	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212725s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212725Orig1s011ltr.pdf
10/20/2023	SUPPL-9	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212725Orig1s009Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212725Orig1s009Correctedltr.pdf
08/31/2023	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212725s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212725Orig1s008ltr.pdf
06/16/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212725s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212725Orig1s007ltr.pdf
07/18/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212725s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212725Orig1s006ltr.pdf
11/05/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212725s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212725Orig1s005ltr.pdf

Labels for NDA 212725

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2024	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212725s011lbl.pdf
10/20/2023	SUPPL-9	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212725Orig1s009Correctedlbl.pdf
08/31/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212725s008lbl.pdf
06/16/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212725s007lbl.pdf
07/18/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212725s006lbl.pdf
11/05/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212725s005lbl.pdf
08/15/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212725s000lbl.pdf

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