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Generated: November 17, 2018

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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 nine drug master file entries for this compound. Thirteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 204078
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 204078
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 68001-329-67 10 CARTON in 1 PACKAGE (68001-329-67) > 1 VIAL, MULTI-DOSE in 1 CARTON (68001-329-66) > 10 mL in 1 VIAL, MULTI-DOSE
BLOXIVERZ neostigmine methylsulfate SOLUTION;INTRAVENOUS 204078 NDA Avadel Legacy Pharmaceuticals, LLC 76014-002 76014-002-10 10 CARTON in 1 PACKAGE (76014-002-10) > 1 VIAL, MULTI-DOSE in 1 CARTON (76014-002-33) > 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5MG/10ML (0.5MG/ML)
Approval Date:May 31, 2013TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/10ML (1MG/ML)
Approval Date:May 31, 2013TE:APRLD:Yes

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