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US Department of Justice
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Healthtrust
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Generated: July 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208405

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NDA 208405 describes NEOSTIGMINE METHYLSULFATE, which is a drug marketed by Amneal Pharms Co, Amphastar Pharms Inc, Dr Reddys Labs Ltd, Eurohlth Intl Sarl, Fresenius Kabi Usa, Luitpold Pharms Inc, and Par Sterile Products, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the NEOSTIGMINE METHYLSULFATE profile page.

The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
Summary for 208405
Tradename:NEOSTIGMINE METHYLSULFATE
Applicant:Par Sterile Products
Ingredient:neostigmine methylsulfate
Patents:0
Therapeutic Class:Antimyasthenic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 208405
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 208405
Suppliers and Packaging for NDA: 208405
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 208405 ANDA Par Pharmaceutical, Inc. 42023-188 N 42023-188-10
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 208405 ANDA Par Pharmaceutical, Inc. 42023-189 N 42023-189-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5MG/10ML (0.5MG/ML)
Approval Date:Apr 26, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/10ML (1MG/ML)
Approval Date:Apr 26, 2017TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Merck
Covington
Moodys
Mallinckrodt
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McKesson
Daiichi Sankyo

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