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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011665

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NDA 011665 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 011665
Tradename:MESTINON
Applicant:Bausch
Ingredient:pyridostigmine bromide
Patents:0
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 Bausch Health US, LLC 0187-3013 0187-3013-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-3013-30)
MESTINON pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 011665 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-301 68682-301-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (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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