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ALTUVIIIO

These highlights do not include all the information needed to use ALTUVIIIO safely and effectively. See full prescribing information for ALTUVIIIO. ALTUVIIIO™ [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl], lyophilized powder for solution, for intravenous use Initial U.S. Approval: 2023

Approved
Approval ID

01411972-df40-4ccf-88f0-d3220e5abda9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 31, 2023

Manufacturers
FDA

Bioverativ Therapeutics Inc.

DUNS: 070517011

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71104-978
Application NumberBLA125771
Product Classification
M
Marketing Category
C73585
G
Generic Name
Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl
Product Specifications
Effective DateMarch 31, 2023
FDA Product Classification

Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71104-983
Application NumberBLA125771
Product Classification
M
Marketing Category
C73585
G
Generic Name
Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl
Product Specifications
Effective DateMarch 31, 2023
FDA Product Classification

Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71104-981
Application NumberBLA125771
Product Classification
M
Marketing Category
C73585
G
Generic Name
Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl
Product Specifications
Effective DateMarch 31, 2023
FDA Product Classification

Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71104-984
Application NumberBLA125771
Product Classification
M
Marketing Category
C73585
G
Generic Name
Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl
Product Specifications
Effective DateMarch 31, 2023
FDA Product Classification

Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71104-982
Application NumberBLA125771
Product Classification
M
Marketing Category
C73585
G
Generic Name
Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl
Product Specifications
Effective DateMarch 31, 2023
FDA Product Classification

Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71104-979
Application NumberBLA125771
Product Classification
M
Marketing Category
C73585
G
Generic Name
Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl
Product Specifications
Effective DateMarch 31, 2023
FDA Product Classification

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ALTUVIIIO - FDA Drug Approval Details