Details for New Drug Application (NDA): 204078

NDA 204078 describes BLOXIVERZ, which is a drug marketed by Exela Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the BLOXIVERZ profile page.

The generic ingredient in BLOXIVERZ 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 204078

Tradename:	BLOXIVERZ
Applicant:	Exela Pharma
Ingredient:	neostigmine methylsulfate
Patents:	0

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	Exela Pharma Sciences, LLC	51754-1200	51754-1200-3	10 SYRINGE, PLASTIC in 1 CARTON (51754-1200-3) / 5 mL in 1 SYRINGE, PLASTIC
BLOXIVERZ	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	204078	NDA	Exela Pharma Sciences, LLC	51754-1210	51754-1210-3	10 CARTON in 1 PACKAGE (51754-1210-3) / 1 VIAL, MULTI-DOSE in 1 CARTON (51754-1210-1) / 10 mL in 1 VIAL, MULTI-DOSE

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

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	5MG/5ML (1MG/ML)
Approval Date:	Oct 27, 2023	TE:		RLD:	Yes

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