Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 8, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 015193

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NDA 015193 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. Sixteen suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 015193
Tradename:MESTINON
Applicant:Bausch
Ingredient:pyridostigmine bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 015193
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 015193
Suppliers and Packaging for NDA: 015193
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESTINON pyridostigmine bromide SYRUP;ORAL 015193 NDA Bausch Health US, LLC 0187-3012 0187-3012-20 473 mL in 1 BOTTLE (0187-3012-20)
MESTINON pyridostigmine bromide SYRUP;ORAL 015193 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-307 68682-307-05 473 mL in 1 BOTTLE (68682-307-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength60MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

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