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 useInitial U.S. Approval: 2008
Approved
Approval ID
e8055dfe-f5cd-4784-84e6-2d105b0d4c91
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2019
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code0781-3484
Application NumberANDA203939
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateDecember 1, 2019
Generic Namefosaprepitant dimeglumine
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Quantity: 375 mg in 5 mL
Code: 3SY5LH9PMK
Classification: IACT
FOSAPREPITANT DIMEGLUMINEActive
Quantity: 150 mg in 5 mL
Code: D35FM8T64X
Classification: ACTIR
EDETATE DISODIUMInactive
Quantity: 18.8 mg in 5 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 75 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT