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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 209933


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NDA 209933 describes NEOSTIGMINE METHYLSULFATE, which is a drug marketed by Adaptis, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Be Pharms, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Sagent Pharms Inc, and Umedica, and is included in eighteen NDAs. It is available from twenty-three 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. Twenty-five suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
Summary for 209933
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 Henry Schein, Inc. 0404-9925 0404-9925-10 1 VIAL, MULTI-DOSE in 1 BAG (0404-9925-10) / 10 mL in 1 VIAL, MULTI-DOSE
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

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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