APPLICATION
ANDA203857
TYPE
ANDA
ORIGINAL APPROVAL
2024-09-25
LATEST ACTION
2025-05-16
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GLATIRAMER ACETATEPrescription
GLATIRAMER ACETATE 20MG/ML · INJECTABLE · SUBCUTANEOUS
Approval history
2025-05-16Labeling · Supplement 2 · standardAP
2024-09-25UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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