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AVONEX

These highlights do not include all the information needed to use AVONEX safely and effectively. See full prescribing information for AVONEX. AVONEX (interferon beta-1a) injection, for intramuscular injectionInitial U.S. Approval: 1996

Approved
Approval ID

d70a39cc-de15-4c12-a1ec-8063b69ea0e1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 31, 2023

Manufacturers
FDA

Biogen Inc.

DUNS: 009492211

Products 4

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

Interferon Beta-1a

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59627-003
Application NumberBLA103628
Product Classification
M
Marketing Category
C73585
G
Generic Name
Interferon Beta-1a
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 22, 2022
FDA Product Classification

INGREDIENTS (6)

Acetic AcidInactive
Quantity: 0.25 mg in 0.5 mL
Code: Q40Q9N063P
Classification: IACT
Polysorbate 20Inactive
Quantity: 0.025 mg in 0.5 mL
Code: 7T1F30V5YH
Classification: IACT
interferon beta-1aActive
Quantity: 30 ug in 0.5 mL
Code: XRO4566Q4R
Classification: ACTIB
Sodium acetateInactive
Quantity: 0.79 mg in 0.5 mL
Code: 4550K0SC9B
Classification: IACT
Arginine HydrochlorideInactive
Quantity: 15.8 mg in 0.5 mL
Code: F7LTH1E20Y
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT

Interferon Beta-1a

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59627-002
Application NumberBLA103628
Product Classification
M
Marketing Category
C73585
G
Generic Name
Interferon Beta-1a
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 22, 2022
FDA Product Classification

INGREDIENTS (6)

interferon beta-1aActive
Quantity: 30 ug in 0.5 mL
Code: XRO4566Q4R
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium acetateInactive
Quantity: 0.79 mg in 0.5 mL
Code: 4550K0SC9B
Classification: IACT
Arginine HydrochlorideInactive
Quantity: 15.8 mg in 0.5 mL
Code: F7LTH1E20Y
Classification: IACT
Acetic AcidInactive
Quantity: 0.25 mg in 0.5 mL
Code: Q40Q9N063P
Classification: IACT
Polysorbate 20Inactive
Quantity: 0.025 mg in 0.5 mL
Code: 7T1F30V5YH
Classification: IACT

interferon beta-1a

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59627-222
Application NumberBLA103628
Product Classification
M
Marketing Category
C73585
G
Generic Name
interferon beta-1a
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 22, 2022
FDA Product Classification

interferon beta-1a

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59627-333
Application NumberBLA103628
Product Classification
M
Marketing Category
C73585
G
Generic Name
interferon beta-1a
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 22, 2022
FDA Product Classification

Drug Labeling Information

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 7/31/2023

RECENT MAJOR CHANGES

Warnings and Precautions (5.8)

7/2023

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AVONEX - FDA Drug Approval Details