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FDA Approval

Anthim

CompanyElusys Therapeutics, Inc. (DUNS: 083819511)

Effective Date

June 7, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Obiltoxaximab(100 mg in 1 mL)

Manufacturing Establishments (5)

Labcorp Early Development Laboratories Ltd.

Labeler

Elusys Therapeutics, Inc.

DUNS Number

006453670

West Services and Solutions LLC

Labeler

Elusys Therapeutics, Inc.

DUNS Number

118935952

Lonza Biologics Inc.

Labeler

Elusys Therapeutics, Inc.

DUNS Number

093149750

Ajinomoto Althea, Inc.

Labeler

Elusys Therapeutics, Inc.

DUNS Number

023050730

Nelson Laboratories

Labeler

Elusys Therapeutics, Inc.

DUNS Number

151663234

Products (1)

Anthim

NDC Product Code

69604-204

Application Number

BLA125509

Marketing Category

BLA (C73585)

Route of Administration

INTRAVENOUS

Effective Date

October 14, 2022

Ingredients

ObiltoxaximabActive

Code: 29Z5DNL48CClass: ACTIBQuantity: 100 mg in 1 mL

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