FDA.reportPublic FDA data

Application 212725

Type
NDA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROZLYTREKENTRECTINIBCAPSULE;ORAL100MGYesNo
002ROZLYTREKENTRECTINIBCAPSULE;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-091RozlytrekENTRECTINIBGenentech, Inc.NDACurrent
50242-091RozlytrekENTRECTINIBGenentech Inc.NDACurrent
50242-091RozlytrekENTRECTINIBGenentech, Inc.NDACurrent
50242-091RozlytrekENTRECTINIBGenentech, Inc.NDACurrent
50242-091RozlytrekENTRECTINIBGenentech Inc.NDACurrent
50242-091RozlytrekENTRECTINIBGenentech Inc.NDACurrent
50242-091RozlytrekENTRECTINIBGenentech Inc.NDACurrent
50242-094RozlytrekENTRECTINIBGenentech, Inc.NDACurrent
50242-094RozlytrekENTRECTINIBGenentech Inc.NDACurrent
50242-094RozlytrekENTRECTINIBGenentech, Inc.NDACurrent
50242-094RozlytrekENTRECTINIBGenentech, Inc.NDACurrent
50242-094RozlytrekENTRECTINIBGenentech Inc.NDACurrent
50242-094RozlytrekENTRECTINIBGenentech Inc.NDACurrent
50242-094RozlytrekENTRECTINIBGenentech Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77349SUPPL 2024-01-29
77322SUPPL 2024-01-29
75968SUPPL 2023-10-27
75960SUPPL 2023-10-20
75346SUPPL 2023-09-01
75334SUPPL 2023-09-01
74553SUPPL 2023-06-20
74545SUPPL 2023-06-20
71614SUPPL2022-07-20
71588SUPPL2022-07-19
69274SUPPL2021-11-08
69272SUPPL2021-11-08
60012ORIG2019-09-16
59802ORIG2019-09-16
59723ORIG2019-08-15