FDA.reportPublic FDA data

Application 212726

Type
NDA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROZLYTREKENTRECTINIBCAPSULE;ORAL100MGYesNo
002ROZLYTREKENTRECTINIBCAPSULE;ORAL200MGYesNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RozlytrekENTRECTINIBGenentech, Inc.c7c71b0c-2549-4495-86b6-c2807fa549082025-12-04Warnings, Adverse reactionsName fallback
brand name: Rozlytrek
generic name: ENTRECTINIB

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60013ORIG2019-09-16
59803ORIG2019-09-16
59736ORIG2019-08-16
62995ORIG1900-01-01