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Generated: November 20, 2017

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Details for New Drug Application (NDA): 208405

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NDA 208405 describes NEOSTIGMINE METHYLSULFATE, which is a drug marketed by Par Sterile Products, Fresenius Kabi Usa, Amphastar Pharms Inc, and Eurohlth Intl Sarl, and is included in four NDAs. It is available from six suppliers. Additional details are available on the NEOSTIGMINE METHYLSULFATE profile page.

The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.

Summary for 208405

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antimyasthenic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 208405

Mechanism of ActionCholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for 208405

Suppliers and Packaging for NDA: 208405

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOSTIGMINE METHYLSULFATE
neostigmine methylsulfate
SOLUTION;INTRAVENOUS 208405 ANDA Par Pharmaceutical, Inc. 42023-188 42023-188-10 10 VIAL, MULTI-DOSE in 1 CARTON (42023-188-10) > 10 mL in 1 VIAL, MULTI-DOSE
NEOSTIGMINE METHYLSULFATE
neostigmine methylsulfate
SOLUTION;INTRAVENOUS 208405 ANDA Par Pharmaceutical, Inc. 42023-189 42023-189-10 10 VIAL, MULTI-DOSE in 1 CARTON (42023-189-10) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5MG/10ML (0.5MG/ML)
Approval Date:Apr 26, 2017TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/10ML (1MG/ML)
Approval Date:Apr 26, 2017TE:APRLD:No


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