Requests that the FDA declare that an ANDA may be submitted for Pyridostigmine Bromide Oral Solution, USP 120􀯗mg/5 mL, a strength that differs from the currently approved RLD, MESTINON® (Pyridostigmine Bromide) Oral Solution, USP 60􀯗mg/5 mL, NDA #015193, held by Bausch Health US, LLC. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-4986

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

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 9, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response	Apr 30, 2026	--

Keywords

CDER

Suitability Petition

Rising Pharma Holdings Inc

declare that an ANDA may be submitted for

Pyridostigmine Bromide Oral Solution

USP 120 mg 5 mL

a strength that

differs from the currently approved RLD

Data from Regulations.gov