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 use Initial U.S. Approval: 2008
Approved
Approval ID
cb36d3fb-4e13-4953-961d-b0e353c94942
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2021
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
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 Code69097-830
Application NumberANDA212309
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJanuary 1, 2021
Generic Namefosaprepitant
INGREDIENTS (6)
FOSAPREPITANT DIMEGLUMINEActive
Quantity: 150 mg in 5 mL
Code: D35FM8T64X
Classification: ACTIR
EDETATE DISODIUMInactive
Quantity: 5.4 mg in 5 mL
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 75 mg in 5 mL
Code: 6OZP39ZG8H
Classification: IACT
ANHYDROUS LACTOSEInactive
Quantity: 375 mg in 5 mL
Code: 3SY5LH9PMK
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT