FDA.reportPublic FDA data

Application 210861

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VITRAKVILAROTRECTINIB SULFATECAPSULE;ORALEQ 25MG BASEYesNo
002VITRAKVILAROTRECTINIB SULFATECAPSULE;ORALEQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-390VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-390VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-390VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-390VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
50419-390VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-390VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-390VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-391VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-391VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-391VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-391VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-391VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-391VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-391VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.NDACurrent
71777-390VITRAKVILAROTRECTINIBLoxo Oncology, Inc.NDACurrent
71777-390VITRAKVILAROTRECTINIBLoxo Oncology, Inc.NDACurrent
71777-391VITRAKVILAROTRECTINIBLoxo Oncology, Inc.NDACurrent
71777-391VITRAKVILAROTRECTINIBLoxo Oncology, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82012SUPPL 2025-04-25
81922SUPPL 2025-04-10
76385SUPPL 2023-11-06
76383SUPPL 2023-11-06
72727SUPPL2022-11-28
72701SUPPL2022-11-25
66917SUPPL2021-03-30
66898SUPPL2021-03-29
66886SUPPL2021-03-26
56768ORIG2018-12-18
56701ORIG2018-12-11
56563ORIG2018-11-26