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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 020645


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NDA 020645 describes AMMONUL, which is a drug marketed by Bausch and is included in one NDA. It is available from two 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 seventy-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.
Summary for 020645
Tradename:AMMONUL
Applicant:Bausch
Ingredient:sodium benzoate; sodium phenylacetate
Patents:0
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 Bausch Health US LLC 0187-0010 0187-0010-50 1 VIAL, SINGLE-USE in 1 CARTON (0187-0010-50) / 50 mL in 1 VIAL, SINGLE-USE
AMMONUL sodium benzoate; sodium phenylacetate SOLUTION;INTRAVENOUS 020645 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-001 68682-001-50 1 VIAL, SINGLE-USE in 1 CARTON (68682-001-50) / 50 mL in 1 VIAL, SINGLE-USE

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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