Irinotecan Hydrochloride
These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE injection, USP safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE injection, USP. IRINOTECAN HYDROCHLORIDE injection USP, intravenous infusion Initial U.S. Approval: 1996
Approved
Approval ID
80f3b79c-a399-45b3-b755-8535457719af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 9, 2019
Manufacturers
FDA
Areva Pharmaceuticals,Inc.
DUNS: 833189835
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Irinotecan Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59923-702
Application NumberANDA077219
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irinotecan Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 9, 2019
FDA Product Classification
INGREDIENTS (5)
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
IRINOTECAN HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 042LAQ1IIS
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT