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FDA Approval

Irinotecan Hydrochloride

CompanyAreva Pharmaceuticals,Inc. (DUNS: 833189835)

Effective Date

April 9, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Irinotecan(20 mg in 1 mL)

Registrants (1)

Areva Pharmaceuticals,Inc.

DUNS Number

833189835

Manufacturing Establishments (1)

Cipla Ltd.- Goa

Labeler

Areva Pharmaceuticals,Inc.

Registrant

Areva Pharmaceuticals,Inc.

DUNS Number

650072015

Products (1)

Irinotecan Hydrochloride

NDC Product Code

59923-702

Application Number

ANDA077219

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

April 9, 2019

Ingredients

LACTIC ACIDInactive

Code: 33X04XA5ATClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

IrinotecanActive

Code: 042LAQ1IISClass: ACTIBQuantity: 20 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

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