AJOVY
These highlights do not include all the information needed to use AJOVY safely and effectively. See full prescribing information for AJOVY.AJOVY (fremanezumab-vfrm) injection, for subcutaneous useInitial U.S. Approval: 2018
Approved
Approval ID
98e344ea-5916-4947-b6f2-4a76ccc04b6b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fremanezumab-vfrm
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51759-204
Application NumberBLA761089
Product Classification
M
Marketing Category
C73585
G
Generic Name
fremanezumab-vfrm
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 12, 2023
FDA Product Classification
INGREDIENTS (6)
FREMANEZUMABActive
Quantity: 225 mg in 1.5 mL
Code: PF8K38CG54
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
DISODIUM ETHYLENEDIAMINEDIACETATEInactive
Code: EQL53S5L0F
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
fremanezumab-vfrm
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51759-202
Application NumberBLA761089
Product Classification
M
Marketing Category
C73585
G
Generic Name
fremanezumab-vfrm
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 12, 2023
FDA Product Classification
INGREDIENTS (6)
FREMANEZUMABActive
Quantity: 225 mg in 1.5 mL
Code: PF8K38CG54
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DISODIUM ETHYLENEDIAMINEDIACETATEInactive
Code: EQL53S5L0F
Classification: IACT