Glatopa
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .GLATOPA (glatiramer acetate injection), for subcutaneous useInitial U.S. Approval: 1996
Approved
Approval ID
028fdf0e-2340-407b-bcd8-5a99accdddbf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code63629-8816
Application NumberANDA206921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glatiramer Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 14, 2021
FDA Product Classification
INGREDIENTS (2)
GLATIRAMER ACETATEActive
Quantity: 40 mg in 1 mL
Code: 5M691HL4BO
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT