Fosaprepitant
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 useInitial U.S. Approval: 2008
Approved
Approval ID
ffee61d1-c1c6-4224-871c-ab7ff6cd01e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FOSAPREPITANT
PRODUCT DETAILS
NDC Product Code63323-972
Application NumberANDA206197
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJune 29, 2020
Generic NameFOSAPREPITANT
INGREDIENTS (6)
FOSAPREPITANT DIMEGLUMINEActive
Quantity: 150 mg in 5 mL
Code: D35FM8T64X
Classification: ACTIR
ANHYDROUS LACTOSEInactive
Quantity: 375 mg in 5 mL
Code: 3SY5LH9PMK
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 18.8 mg in 5 mL
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 75 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT