Manufacturing Establishments9
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Penn Pharmaceutical Services Ltd
Bayer HealthCare Pharmaceuticals Inc.
226277259
W. R. Grace & Co.-Conn.
Bayer HealthCare Pharmaceuticals Inc.
788779192
Orion Corporation, Orion Pharma
Bayer HealthCare Pharmaceuticals Inc.
368380223
Sharp Corporation
Bayer HealthCare Pharmaceuticals Inc.
143696495
Wickham Micro Limited
Bayer HealthCare Pharmaceuticals Inc.
228216353
Avista Pharma Solutions, Inc. dba Cambrex
Bayer HealthCare Pharmaceuticals Inc.
144616641
Currenta GmbH & Co. OHG
Bayer HealthCare Pharmaceuticals Inc.
331575303
NEXTPHARMA PLOERMEL
Bayer HealthCare Pharmaceuticals Inc.
493010524
Butterworth Laboratories Ltd
Bayer HealthCare Pharmaceuticals Inc.
225081538
Products4
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
50419-393Application Number
NDA211710Marketing Category
NDA (C73594)Route of Administration
OROPHARYNGEALEffective Date
December 6, 2022LarotrectinibActive
Code: PF9462I9HXClass: ACTIBQuantity: 20 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
HYDROXYPROPYL BETADEXInactive
Code: 1I96OHX6EKClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULRClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
VITRAKVI
Product Details
NDC Product Code
50419-392Application Number
NDA211710Marketing Category
NDA (C73594)Route of Administration
OROPHARYNGEALEffective Date
December 6, 2022SUCROSEInactive
Code: C151H8M554Class: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
LarotrectinibActive
Code: PF9462I9HXClass: ACTIMQuantity: 20 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SODIUM PHOSPHATEInactive
Code: SE337SVY37Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
ADRABETADEXInactive
Code: 8W6Q67R6NXClass: IACT
VITRAKVI
Product Details
NDC Product Code
50419-391Application Number
NDA210861Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 6, 2022LarotrectinibActive
Code: PF9462I9HXClass: ACTIMQuantity: 100 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
VITRAKVI
Product Details
NDC Product Code
50419-390Application Number
NDA210861Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 6, 2022LarotrectinibActive
Code: PF9462I9HXClass: ACTIMQuantity: 25 mg in 1 1
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT