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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207096

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NDA 207096 describes SODIUM PHENYLACETATE AND SODIUM BENZOATE, which is a drug marketed by Ailex Pharms Llc, Maia Pharms Inc, and Navinta Llc, and is included in three NDAs. It is available from four suppliers. Additional details are available on the SODIUM PHENYLACETATE AND SODIUM BENZOATE profile page.

The generic ingredient in SODIUM PHENYLACETATE AND SODIUM BENZOATE 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 207096
Applicant:Ailex Pharms Llc
Ingredient:sodium benzoate; sodium phenylacetate
Formulation / Manufacturing:see details
Pharmacology for NDA: 207096
Mechanism of ActionAmmonium Ion Binding Activity
Suppliers and Packaging for NDA: 207096
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM PHENYLACETATE AND SODIUM BENZOATE sodium benzoate; sodium phenylacetate SOLUTION;IV (INFUSION) 207096 ANDA Trigen Laboratories, LLC 13811-705 N 13811-705-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength10%;10% (5GM/50ML;5GM/50ML)
Approval Date:Feb 24, 2016TE:APRLD:No

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