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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 009829


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NDA 009829 describes MESTINON, which is a drug marketed by Bausch and is included in four NDAs. It is available from three suppliers. Additional details are available on the MESTINON profile page.

The generic ingredient in MESTINON is pyridostigmine bromide. There are eleven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 009829
Tradename:MESTINON
Applicant:Bausch
Ingredient:pyridostigmine bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 009829
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 009829
Suppliers and Packaging for NDA: 009829
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESTINON pyridostigmine bromide TABLET;ORAL 009829 NDA Bausch Health US, LLC 0187-3010 0187-3010-30 100 TABLET in 1 BOTTLE (0187-3010-30)
MESTINON pyridostigmine bromide TABLET;ORAL 009829 NDA AUTHORIZED GENERIC AvPAK 50268-638 50268-638-15 50 TABLET in 1 BOX (50268-638-15)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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