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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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Queensland Health
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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205650

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NDA 205650 describes PYRIDOSTIGMINE BROMIDE, which is a drug marketed by Alvogen Malta, Impax Labs Inc, Kinedexe Uk, Ani Pharms Inc, Impax Labs, Solvay, Us Army, and Zydus Pharms Usa Inc, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the PYRIDOSTIGMINE BROMIDE profile page.

The generic ingredient in PYRIDOSTIGMINE BROMIDE 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 205650
Applicant:Zydus Pharms Usa Inc
Ingredient:pyridostigmine bromide
Therapeutic Class:Antimyasthenic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205650
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 205650
Suppliers and Packaging for NDA: 205650
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 205650 ANDA Major Pharmaceuticals 0904-6622 N 0904-6622-61
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 205650 ANDA Bryant Ranch Prepack 63629-5699 N 63629-5699-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Jun 22, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Express Scripts
Harvard Business School

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