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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: June 20, 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. Eight suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.
Summary for 020645
Ingredient:sodium benzoate; sodium phenylacetate
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;INTRAVENOUS 020645 NDA Valeant Pharmaceuticals North America LLC 0187-0010 N 0187-0010-50
AMMONUL sodium benzoate; sodium phenylacetate SOLUTION;INTRAVENOUS 020645 NDA Ucyclyd Pharma Inc. 62592-720 N 62592-720-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10%;10% (5GM/50ML;5GM/50ML)
Approval Date:Feb 17, 2005TE:APRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Federal Trade Commission

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