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Last Updated: June 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209182


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NDA 209182 describes NEOSTIGMINE METHYLSULFATE, which is a drug marketed by Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Be Pharms, Dr Reddys, Eurohlth Intl Sarl, Fresenius Kabi Usa, Gland Pharma Ltd, and Par Sterile Products, and is included in ten 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. Eleven suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
Summary for 209182
Tradename:NEOSTIGMINE METHYLSULFATE
Applicant:Am Regent
Ingredient:neostigmine methylsulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209182
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 209182
Suppliers and Packaging for NDA: 209182
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209182 ANDA American Regent, Inc. 0517-1133 0517-1133-05 5 VIAL, MULTI-DOSE in 1 CARTON (0517-1133-05) > 10 mL in 1 VIAL, MULTI-DOSE (0517-1133-01)
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209182 ANDA American Regent, Inc. 0517-1134 0517-1134-05 5 VIAL, MULTI-DOSE in 1 CARTON (0517-1134-05) > 10 mL in 1 VIAL, MULTI-DOSE (0517-1134-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5MG/10ML (0.5MG/ML)
Approval Date:May 4, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/10ML (1MG/ML)
Approval Date:May 4, 2018TE:APRLD:No

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