Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Packaging Coordinators, LLC
Biogen Inc.
078525133
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Avonex Pen
Product Details
NDC Product Code
59627-003Application Number
BLA103628Marketing Category
BLA (C73585)Route of Administration
INTRAMUSCULAREffective Date
November 22, 2022Acetic AcidInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.25 mg in 0.5 mL
Polysorbate 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 0.025 mg in 0.5 mL
Interferon beta-1aActive
Code: XRO4566Q4RClass: ACTIBQuantity: 30 ug in 0.5 mL
Sodium acetateInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.79 mg in 0.5 mL
Arginine HydrochlorideInactive
Code: F7LTH1E20YClass: IACTQuantity: 15.8 mg in 0.5 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Avonex
Product Details
NDC Product Code
59627-002Application Number
BLA103628Marketing Category
BLA (C73585)Route of Administration
INTRAMUSCULAREffective Date
November 22, 2022Interferon beta-1aActive
Code: XRO4566Q4RClass: ACTIBQuantity: 30 ug in 0.5 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium acetateInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.79 mg in 0.5 mL
Arginine HydrochlorideInactive
Code: F7LTH1E20YClass: IACTQuantity: 15.8 mg in 0.5 mL
Acetic AcidInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.25 mg in 0.5 mL
Polysorbate 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 0.025 mg in 0.5 mL
AVONEX
Product Details
NDC Product Code
59627-222Application Number
BLA103628Marketing Category
BLA (C73585)Route of Administration
INTRAMUSCULAREffective Date
November 22, 2022AVONEX
Product Details
NDC Product Code
59627-333Application Number
BLA103628Marketing Category
BLA (C73585)Route of Administration
INTRAMUSCULAREffective Date
November 22, 2022Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
RECENT MAJOR CHANGES SECTION
RECENT MAJOR CHANGES
|
Warnings and Precautions (5.8) |
7/2023 |