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FDA Routing Summary for ANDA 203857 – Glatiramer Acetate Injection 20 mg/mL
FDA Routing Summary for ANDA 203857 – Glatiramer Acetate Injection 20 mg/mL
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Original Request: Pursuant to the authority of Freedom of Information Act, I hereby request the Routing Summary for ANDA No. 203857 for Glatiramer Acetate Injection, 20 mg/mL submitted by Synthon Pharmaceuticals, Inc.
Tags: Pharma, ANDA, 2025
Tags: Pharma, ANDA, 2025
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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