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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

0679689e-8930-4d6a-b922-5125082b2716

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 Code63629-8815
Application NumberANDA090218
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)

MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
GLATIRAMER ACETATEActive
Quantity: 20 mg in 1 mL
Code: 5M691HL4BO
Classification: ACTIB

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Glatopa - FDA Drug Approval Details