MedPath
FDA Approval

Irinotecan Hydrochloride

June 28, 2020

HUMAN PRESCRIPTION DRUG LABEL

Irinotecan(20 mg in 1 mL)

Manufacturing Establishments (1)

THYMOORGAN GMBH PHARMAZIE

Hikma Pharmaceuticals USA Inc.

319029989

Products (1)

Irinotecan Hydrochloride

0143-9583

ANDA091032

ANDA (C73584)

INTRAVENOUS

June 28, 2020

Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL
LACTIC ACIDInactive
Code: 33X04XA5ATClass: IACTQuantity: 0.9 mg in 1 mL
SORBITOLInactive
Code: 506T60A25RClass: IACTQuantity: 45 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
© Copyright 2025. All Rights Reserved by MedPath