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Last Updated: June 4, 2020

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Details for New Drug Application (NDA): 210051


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NDA 210051 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 210051
Tradename:NEOSTIGMINE METHYLSULFATE
Applicant:Amneal
Ingredient:neostigmine methylsulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210051
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 210051
Suppliers and Packaging for NDA: 210051
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 210051 ANDA Amneal Pharmaceuticals LLC 70121-1478 70121-1478-7 10 VIAL, MULTI-DOSE in 1 CARTON (70121-1478-7) > 10 mL in 1 VIAL, MULTI-DOSE (70121-1478-1)
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 210051 ANDA Amneal Pharmaceuticals LLC 70121-1479 70121-1479-7 10 VIAL, MULTI-DOSE in 1 CARTON (70121-1479-7) > 10 mL in 1 VIAL, MULTI-DOSE (70121-1479-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5MG/10ML (0.5MG/ML)
Approval Date:Jun 15, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/10ML (1MG/ML)
Approval Date:Jun 15, 2018TE:APRLD:No

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