MedPath
FDA Approval

IRINOTECAN HYDROCHLORIDE

July 25, 2023

Human Prescription Drug Label

Irinotecan(20 mg in 1 mL)

Manufacturing Establishments (1)

EUGIA Pharma Specialities Limited

Eugia US LLC

872201704

Products (4)

IRINOTECAN HYDROCHLORIDE

55150-352

ANDA213278

ANDA (C73584)

INTRAVENOUS

July 25, 2023

Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL
SORBITOLInactive
Code: 506T60A25RClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

IRINOTECAN HYDROCHLORIDE

55150-353

ANDA213278

ANDA (C73584)

INTRAVENOUS

July 25, 2023

SORBITOLInactive
Code: 506T60A25RClass: IACT
Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

IRINOTECAN HYDROCHLORIDE

55150-355

ANDA213278

ANDA (C73584)

INTRAVENOUS

July 25, 2023

SORBITOLInactive
Code: 506T60A25RClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

IRINOTECAN HYDROCHLORIDE

55150-354

ANDA213278

ANDA (C73584)

INTRAVENOUS

July 25, 2023

SORBITOLInactive
Code: 506T60A25RClass: IACT
Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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