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
5bb41bcb-c775-4447-9bd0-d4c55ad110ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2022
Manufacturers
FDA
Qilu Pharmaceutical Co., Ltd.
DUNS: 653878256
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67184-0540
Application NumberANDA213106
Product Classification
M
Marketing Category
C73584
G
Generic Name
FOSAPREPITANT DIMEGLUMINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 11, 2022
FDA Product Classification
INGREDIENTS (6)
FOSAPREPITANT DIMEGLUMINEActive
Quantity: 150 mg in 5 mL
Code: D35FM8T64X
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 75 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 5.4 mg in 5 mL
Code: 7FLD91C86K
Classification: IACT
ANHYDROUS LACTOSEInactive
Quantity: 375 mg in 5 mL
Code: 3SY5LH9PMK
Classification: IACT