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Serving leading biopharmaceutical companies globally:

US Department of Justice
Teva
Citi
Fish and Richardson
Baxter
Novartis
Chubb
Daiichi Sankyo
Boehringer Ingelheim
Covington

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 009829

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NDA 009829 describes MESTINON, which is a drug marketed by Valeant Pharm Intl, Valeant Pharms, and Valeant Pharms Llc, and is included in four NDAs. It is available from two 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. Ten suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 009829
Tradename:MESTINON
Applicant:Valeant Pharms Llc
Ingredient:pyridostigmine bromide
Patents:0
Therapeutic Class:Antimyasthenic Agents
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 Valeant Pharmaceuticals North America LLC 0187-3010 N 0187-3010-30
MESTINON pyridostigmine bromide TABLET;ORAL 009829 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-302 N 68682-302-10

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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QuintilesIMS
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US Army
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