Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204078

« Back to Dashboard

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. Eleven 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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School

Baxter

Colorcon

Daiichi Sankyo

Chubb

UBS

AstraZeneca

Argus Health

Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.