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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212804


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NDA 212804 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 212804
Tradename:NEOSTIGMINE METHYLSULFATE
Applicant:Meitheal
Ingredient:neostigmine methylsulfate
Patents:0
Pharmacology for NDA: 212804
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 212804
Suppliers and Packaging for NDA: 212804
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 212804 ANDA Meitheal Pharmaceuticals Inc. 71288-500 71288-500-11 10 VIAL, MULTI-DOSE in 1 CARTON (71288-500-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-500-10)
NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 212804 ANDA Meitheal Pharmaceuticals Inc. 71288-501 71288-501-11 10 VIAL, MULTI-DOSE in 1 CARTON (71288-501-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-501-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5MG/10ML (0.5MG/ML)
Approval Date:Apr 5, 2021TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/10ML (1MG/ML)
Approval Date:Apr 5, 2021TE:APRLD:No

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