Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Helsinn Healthcare SA
481466936
Manufacturing Establishments4
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Helsinn Advanced Synthesis SA
Helsinn Therapeutics (U.S.), Inc.
Helsinn Healthcare SA
481296960
Patheon Italia S.p.A.
Helsinn Therapeutics (U.S.), Inc.
Helsinn Healthcare SA
338336589
Baxter Oncology GmbH
Helsinn Therapeutics (U.S.), Inc.
Helsinn Healthcare SA
344276063
Helsinn Birex Pharmaceuticals LTD
Helsinn Therapeutics (U.S.), Inc.
Helsinn Healthcare SA
985084409
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
AKYNZEO
Product Details
NDC Product Code
69639-102Application Number
NDA210493Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
February 10, 2023PalonosetronActive
Code: 23310D4I19Class: ACTIMQuantity: 0.28 mg in 1 1
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
FosnetupitantActive
Code: T672P80L2SClass: ACTIMQuantity: 260 mg in 1 1
AKYNZEO
Product Details
NDC Product Code
69639-105Application Number
NDA210493Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
February 10, 2023FosnetupitantActive
Code: T672P80L2SClass: ACTIMQuantity: 260 mg in 20 mL
PalonosetronActive
Code: 23310D4I19Class: ACTIMQuantity: 0.28 mg in 20 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
AKYNZEO
Product Details
NDC Product Code
69639-106Application Number
NDA210493Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
February 10, 2023HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
PalonosetronActive
Code: 23310D4I19Class: ACTIMQuantity: 0.28 mg in 20 mL
FosnetupitantActive
Code: T672P80L2SClass: ACTIMQuantity: 260 mg in 20 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
AKYNZEO
Product Details
NDC Product Code
69639-101Application Number
NDA205718Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
February 10, 2023WATERInactive
Code: 059QF0KO0RClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYGLYCERYL-3 DIOLEATEInactive
Code: D08AL46IU2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
PalonosetronActive
Code: 5D06587D6RClass: ACTIBQuantity: 0.5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SUCROSE LAURATEInactive
Code: 05Q7CD0E49Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESInactive
Code: U72Q2I8C85Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
NetupitantActive
Code: 7732P08TIRClass: ACTIBQuantity: 300 mg in 1 1