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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204078

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NDA 204078 describes BLOXIVERZ, which is a drug marketed by Avadel Legacy and is included in one NDA. It is available from two suppliers. Additional details are available on the BLOXIVERZ profile page.

The generic ingredient in BLOXIVERZ is neostigmine methylsulfate. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.

Summary for 204078

Tradename:	BLOXIVERZ
Applicant:	Avadel Legacy
Ingredient:	neostigmine methylsulfate
Patents:	0
Therapeutic Class:	Antimyasthenic Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 204078

Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for 204078

Cholinesterase Inhibitors
Parasympathomimetics

Suppliers and Packaging for NDA: 204078

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BLOXIVERZ	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	204078	NDA	BluePoint Laboratories	68001-329	N	68001-329-67
BLOXIVERZ	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	204078	NDA	Avadel Legacy Pharmaceuticals, LLC	76014-002	N	76014-002-10

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	5MG/10ML (0.5MG/ML)
Approval Date:	May 31, 2013	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	10MG/10ML (1MG/ML)
Approval Date:	May 31, 2013	TE:	AP	RLD:	Yes

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