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FDA Approval

Elzonris

CompanyStemline Therapeutics, Inc. (DUNS: 139606136)

Effective Date

July 31, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Tagraxofusp(1000 ug in 1 mL)

Manufacturing Establishments (1)

Alcami Carolinas Corporation

Labeler

Stemline Therapeutics, Inc.

DUNS Number

832394733

Products (1)

Elzonris

NDC Product Code

72187-0401

Application Number

BLA761116

Marketing Category

BLA (C73585)

Route of Administration

INTRAVENOUS

Effective Date

December 31, 2018

Ingredients

TagraxofuspActive

Code: 8ZHS5657EHClass: ACTIBQuantity: 1000 ug in 1 mL

SORBITOLInactive

Code: 506T60A25RClass: IACTQuantity: 50 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 4.38 mg in 1 mL

TROMETHAMINEInactive

Code: 023C2WHX2VClass: IACTQuantity: 2.42 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

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