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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204078

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NDA 204078 describes BLOXIVERZ, which is a drug marketed by Eclat Pharms Llc 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 six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.

Summary for NDA: 204078

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

Pharmacology for NDA: 204078

Mechanism of ActionCholinesterase Inhibitors

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 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
BLOXIVERZ
neostigmine methylsulfate
SOLUTION;INTRAVENOUS 204078 NDA Avadel Legacy Pharmaceuticals, LLC 76014-003 76014-003-10 10 CARTON in 1 PACKAGE (76014-003-10) > 1 VIAL, MULTI-DOSE in 1 CARTON (76014-003-33) > 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:May 31, 2013TE:APRLD:Yes

Summary 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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Serving 500+ biopharmaceutical companies globally:

Novartis
QuintilesIMS
Express Scripts
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Harvard Business School
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