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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020645

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NDA 020645 describes AMMONUL, which is a drug marketed by Medicis and is included in one NDA. It is available from three suppliers. Additional details are available on the AMMONUL profile page.

The generic ingredient in AMMONUL is sodium benzoate; sodium phenylacetate. There are one thousand four hundred and twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.
Summary for 020645
Tradename:AMMONUL
Applicant:Medicis
Ingredient:sodium benzoate; sodium phenylacetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020645
Mechanism of ActionAmmonium Ion Binding Activity
Suppliers and Packaging for NDA: 020645
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMMONUL sodium benzoate; sodium phenylacetate SOLUTION;IV (INFUSION) 020645 NDA Valeant Pharmaceuticals North America LLC 0187-0010 N 0187-0010-50
AMMONUL sodium benzoate; sodium phenylacetate SOLUTION;IV (INFUSION) 020645 NDA Ucyclyd Pharma Inc. 62592-720 N 62592-720-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength10%;10% (5GM/50ML;5GM/50ML)
Approval Date:Feb 17, 2005TE:APRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
US Army
Express Scripts
Deloitte
Boehringer Ingelheim
Farmers Insurance
Daiichi Sankyo
Cerilliant
Mallinckrodt

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