FOSAPREPITANT DIMEGLUMINE
These highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. See full prescribing information for FOSAPREPITANT FOR INJECTION. FOSAPREPITANT for injection, for intravenous use Initial U.S. Approval: 2008
Approved
Approval ID
1cc7d482-5d45-4621-9ffc-cd3f7c54614d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2021
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FOSAPREPITANT DIMEGLUMINE
PRODUCT DETAILS
NDC Product Code0143-9384
Application NumberANDA213106
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 27, 2021
Generic NameFOSAPREPITANT DIMEGLUMINE
INGREDIENTS (6)
EDETATE DISODIUMInactive
Quantity: 5.4 mg in 5 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FOSAPREPITANT DIMEGLUMINEActive
Quantity: 150 mg in 5 mL
Code: D35FM8T64X
Classification: ACTIR
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ANHYDROUS LACTOSEInactive
Quantity: 375 mg in 5 mL
Code: 3SY5LH9PMK
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 75 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT