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Last Updated: June 13, 2021

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Details for New Drug Application (NDA): 209933


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NDA 209933 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, Hong Kong, and Par Sterile Products, and is included in eleven NDAs. It is available from twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
Summary for 209933
Tradename:NEOSTIGMINE METHYLSULFATE
Applicant:Amphastar Pharms Inc
Ingredient:neostigmine methylsulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209933
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 209933
Suppliers and Packaging for NDA: 209933
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209933 ANDA Amphastar Pharmaceuticals, Inc. 0548-9601 0548-9601-00 10 CARTON in 1 PACKAGE (0548-9601-00) > 1 VIAL, MULTI-DOSE in 1 CARTON > 10 mL in 1 VIAL, MULTI-DOSE
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209933 ANDA Amphastar Pharmaceuticals, Inc. 0548-9602 0548-9602-00 10 CARTON in 1 PACKAGE (0548-9602-00) > 1 VIAL, MULTI-DOSE in 1 CARTON > 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:Sep 25, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/10ML (1MG/ML)
Approval Date:Sep 25, 2017TE:APRLD:No

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