MedPath
FDA Approval

Irinotecan Hydrochloride

January 14, 2021

HUMAN PRESCRIPTION DRUG LABEL

Irinotecan(20 mg in 1 mL)

Products (3)

Irinotecan Hydrochloride

59923-715

ANDA208718

ANDA (C73584)

INTRAVENOUS

January 14, 2021

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

Irinotecan Hydrochloride

59923-714

ANDA208718

ANDA (C73584)

INTRAVENOUS

January 14, 2021

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

Irinotecan Hydrochloride

59923-716

ANDA208718

ANDA (C73584)

INTRAVENOUS

January 14, 2021

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