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Ixinity

These highlights do not include all the information needed to use IXINITY® safely and effectively. See full prescribing information for IXINITY.. IXINITY [coagulation factor IX (recombinant)] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2015

Approved
Approval ID

9521898c-61aa-44ab-8ab8-84274ca19943

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 23, 2021

Manufacturers
FDA

Aptevo BioTherapeutics LLC

DUNS: 080160602

Products 6

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

coagulation factor IX (recombinant)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70504-0283
Application NumberBLA125426
Product Classification
M
Marketing Category
C73585
G
Generic Name
coagulation factor IX (recombinant)
Product Specifications
Effective DateJune 14, 2018
FDA Product Classification

coagulation factor IX (recombinant)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70504-0282
Application NumberBLA125426
Product Classification
M
Marketing Category
C73585
G
Generic Name
coagulation factor IX (recombinant)
Product Specifications
Effective DateJune 14, 2018
FDA Product Classification

coagulation factor IX (recombinant)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70504-0288
Application NumberBLA125426
Product Classification
M
Marketing Category
C73585
G
Generic Name
coagulation factor IX (recombinant)
Product Specifications
Effective DateJune 14, 2018
FDA Product Classification

coagulation factor IX (recombinant)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70504-0289
Application NumberBLA125426
Product Classification
M
Marketing Category
C73585
G
Generic Name
coagulation factor IX (recombinant)
Product Specifications
Effective DateJune 14, 2018
FDA Product Classification

coagulation factor IX (recombinant)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70504-0284
Application NumberBLA125426
Product Classification
M
Marketing Category
C73585
G
Generic Name
coagulation factor IX (recombinant)
Product Specifications
Effective DateJune 14, 2018
FDA Product Classification

coagulation factor IX (recombinant)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70504-0287
Application NumberBLA125426
Product Classification
M
Marketing Category
C73585
G
Generic Name
coagulation factor IX (recombinant)
Product Specifications
Effective DateJune 14, 2018
FDA Product Classification

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Ixinity - FDA Drug Approval Details