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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 Fresenius Kabi Usa and Eurohlth Intl Sarl and is included in two NDAs. It is available from four suppliers. Additional details are available on the NEOSTIGMINE METHYLSULFATE profile page.

The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.

Summary for NDA: 203629

Fresenius Kabi Usa
neostigmine methylsulfate
Therapeutic Class:Antimyasthenic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203629

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 203629

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
SOLUTION;INTRAVENOUS 203629 NDA REMEDYREPACK INC. 61786-452 61786-452-08 10 mL in 1 VIAL, MULTI-DOSE (61786-452-08)

Summary for product number 001

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

Summary 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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