VITRAKVI
These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI (larotrectinib) capsules, for oral use VITRAKVI (larotrectinib) oral solutionInitial U.S. Approval: 2018
Approved
Approval ID
9525f887-a055-4e33-8e92-898d42828cd1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2018
Manufacturers
FDA
Loxo Oncology, Inc.
DUNS: 042572897
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LAROTRECTINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71777-391
Application NumberNDA210861
Product Classification
M
Marketing Category
C73594
G
Generic Name
LAROTRECTINIB
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2018
FDA Product Classification
INGREDIENTS (3)
LAROTRECTINIBActive
Quantity: 100 mg in 1 1
Code: PF9462I9HX
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LAROTRECTINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71777-392
Application NumberNDA211710
Product Classification
M
Marketing Category
C73594
G
Generic Name
LAROTRECTINIB
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2018
FDA Product Classification
INGREDIENTS (12)
LAROTRECTINIBActive
Quantity: 20 mg in 1 mL
Code: PF9462I9HX
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HYDROXYPROPYL BETADEX (0.6 HYDROXYPROPYL RESIDUES PER GLUCOSE)Inactive
Code: 8W6Q67R6NX
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM PHOSPHATEInactive
Code: SE337SVY37
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
LAROTRECTINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71777-390
Application NumberNDA210861
Product Classification
M
Marketing Category
C73594
G
Generic Name
LAROTRECTINIB
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2018
FDA Product Classification
INGREDIENTS (3)
LAROTRECTINIBActive
Quantity: 25 mg in 1 1
Code: PF9462I9HX
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT