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
5f01e40a-b6f6-40fb-b37c-3d06f1428e86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code0781-3250
Application NumberANDA206921
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glatiramer Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 31, 2018
FDA Product Classification
INGREDIENTS (2)
GLATIRAMER ACETATEActive
Quantity: 40 mg in 1 mL
Code: 5M691HL4BO
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Glatiramer Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-3234
Application NumberANDA090218
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glatiramer Acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 31, 2018
FDA Product Classification
INGREDIENTS (2)
GLATIRAMER ACETATEActive
Quantity: 20 mg in 1 mL
Code: 5M691HL4BO
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT