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Generated: January 20, 2019

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Details for New Drug Application (NDA): 203629

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NDA 203629 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, Par Sterile Products, and Renaissance Ssa Llc, and is included in eight 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 nine 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 203629
Tradename:NEOSTIGMINE METHYLSULFATE
Applicant:Fresenius Kabi Usa
Ingredient:neostigmine methylsulfate
Patents:0
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 Fresenius Kabi USA, LLC 63323-413 63323-413-10 10 VIAL, MULTI-DOSE in 1 TRAY (63323-413-10) > 10 mL in 1 VIAL, MULTI-DOSE

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength3MG/3ML (1MG/ML)
Approval Date:Sep 18, 2018TE:RLD:No

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