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Serving leading biopharmaceutical companies globally:

Cipla
Mallinckrodt
Julphar
McKesson
Novartis
Medtronic
QuintilesIMS
Johnson and Johnson
Chubb
Moodys

Generated: January 16, 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 six 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
Tradename:NEOSTIGMINE METHYLSULFATE
Applicant:Fresenius Kabi Usa
Ingredient:neostigmine methylsulfate
Patents:0
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 52584-415-10 1 VIAL, MULTI-DOSE in 1 BAG (52584-415-10) > 10 mL in 1 VIAL, MULTI-DOSE
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 203629 NDA REMEDYREPACK INC. 61786-452 61786-452-08 10 mL in 1 VIAL, MULTI-DOSE (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 leading biopharmaceutical companies globally:

Mallinckrodt
Citi
Teva
Harvard Business School
Chinese Patent Office
Fuji
Chubb
US Army
QuintilesIMS

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