FDA.reportPublic FDA data

Application 211710

Type
NDA
Sponsor
BAYER HEALTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VITRAKVILAROTRECTINIB SULFATESOLUTION;ORALEQ 20MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-392VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-392VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-392VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-392VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-392VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-392VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-392VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-393VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
71777-392VITRAKVILAROTRECTINIBLoxo Oncology, Inc.NDACurrent
71777-392VITRAKVILAROTRECTINIBLoxo Oncology, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82013SUPPL 2025-04-25
81925SUPPL 2025-04-16
76370SUPPL 2023-11-06
76369SUPPL 2023-11-06
72728SUPPL2022-11-28
72702SUPPL2022-11-25
66918SUPPL2021-03-30
66899SUPPL2021-03-29
66887SUPPL2021-03-26
66885SUPPL2021-03-26
56772ORIG2018-12-18
56702ORIG2018-12-11
56562ORIG2018-11-26