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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Express Scripts
Farmers Insurance
Daiichi Sankyo

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011665

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NDA 011665 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 011665
Applicant:Valeant Pharms Llc
Ingredient:pyridostigmine bromide
Therapeutic Class:Antimyasthenic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 011665
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 011665
Suppliers and Packaging for NDA: 011665
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESTINON pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 011665 NDA Valeant Pharmaceuticals North America LLC 0187-3013 N 0187-3013-30
MESTINON pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 011665 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-301 N 68682-301-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Fish and Richardson
Johnson and Johnson
US Army

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