Copaxone
These highlights do not include all the information needed to use COPAXONE safely and effectively. See full prescribing information for COPAXONE. COPAXONE (glatiramer acetate injection), for subcutaneous useInitial U.S. Approval: 1996
Approved
Approval ID
aa88f583-4f5f-433b-80b4-1f4c9fb28357
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
Teva Neuroscience, Inc.
DUNS: 009906397
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glatiramer Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68546-317
Application NumberNDA020622
Product Classification
M
Marketing Category
C73594
G
Generic Name
Glatiramer Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 20, 2023
FDA Product Classification
INGREDIENTS (2)
GLATIRAMER ACETATEActive
Quantity: 20 mg in 1 mL
Code: 5M691HL4BO
Classification: ACTIB
MANNITOLInactive
Quantity: 40 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
Glatiramer Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68546-325
Application NumberNDA020622
Product Classification
M
Marketing Category
C73594
G
Generic Name
Glatiramer Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 20, 2023
FDA Product Classification
INGREDIENTS (2)
GLATIRAMER ACETATEActive
Quantity: 40 mg in 1 mL
Code: 5M691HL4BO
Classification: ACTIB
MANNITOLInactive
Quantity: 40 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT