Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Loxo Oncology, Inc.
042572897
Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Albemarle Corporation
Loxo Oncology, Inc.
Loxo Oncology, Inc.
788779192
Sharp Corporation
Loxo Oncology, Inc.
Loxo Oncology, Inc.
143696495
Penn Pharmaceutical Services Ltd
Loxo Oncology, Inc.
Loxo Oncology, Inc.
226277259
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VITRAKVI
Product Details
NDC Product Code
71777-391Application Number
NDA210861Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 5, 2018LarotrectinibActive
Code: PF9462I9HXClass: ACTIMQuantity: 100 mg in 1 1
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
VITRAKVI
Product Details
NDC Product Code
71777-392Application Number
NDA211710Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 5, 2018LarotrectinibActive
Code: PF9462I9HXClass: ACTIMQuantity: 20 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
HYDROXYPROPYL BETADEX (0.6 HYDROXYPROPYL RESIDUES PER GLUCOSE)Inactive
Code: 8W6Q67R6NXClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM PHOSPHATEInactive
Code: SE337SVY37Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
VITRAKVI
Product Details
NDC Product Code
71777-390Application Number
NDA210861Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 5, 2018LarotrectinibActive
Code: PF9462I9HXClass: ACTIMQuantity: 25 mg in 1 1
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT