FDA ANDA 206873, GLATIRAMER ACETATE, SYNTHON PHARMS INC, 09/25/2024

Content: Summary Basis of Approval for the Glatiramer Acetate Injection, 40 mg/mL application #A206873, approved on September 25, 2024.

ANDA: 206873
Company: SYNTHON PHARMS INC
Drug Name: GLATIRAMER ACETATE
Active Ingredients: GLATIRAMER ACETATE
Strength: 40MG/ML
Dosage Form/Route: INJECTABLE;SUBCUTANEOUS
Action Date: 09/25/2024
Marketing Status: Prescription
Submission Classification: ORIG-1

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