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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Fish and Richardson
Boehringer Ingelheim

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203629

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NDA 203629 describes NEOSTIGMINE METHYLSULFATE, which is a drug marketed by Amphastar Pharms Inc, Eurohlth Intl Sarl, Fresenius Kabi Usa, and Par Sterile Products, and is included in four NDAs. It is available from six suppliers. Additional details are available on the NEOSTIGMINE METHYLSULFATE profile page.

The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
Summary for 203629
Applicant:Fresenius Kabi Usa
Ingredient:neostigmine methylsulfate
Therapeutic Class:Antimyasthenic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203629
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 203629
Suppliers and Packaging for NDA: 203629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 203629 NDA General Injectables and Vaccines, Inc 52584-415 N 52584-415-10
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 203629 NDA REMEDYREPACK INC. 61786-452 N 61786-452-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5MG/10ML (0.5MG/ML)
Approval Date:Jan 8, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/10ML (1MG/ML)
Approval Date:Jan 8, 2015TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Fish and Richardson
US Army

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