Requests that the FDA declare that an ANDA may be submitted for Pyridostigmine Bromide Oral Solution, USP 120mg/5 mL, a strength that differs from the currently approved RLD, MESTINON® (Pyridostigmine Bromide) Oral Solution, USP 60mg/5 mL, NDA #015193, held by Bausch Health US, LLC.
🏛 Food and Drug Administration (FDA)FDA-2025-P-4986
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