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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205880

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NDA 205880 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 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 205880

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 205880

Mechanism of ActionAmmonium Ion Binding Activity

Suppliers and Packaging for NDA: 205880

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) 205880 ANDA Zydus Pharmaceuticals USA Inc. 68382-396 68382-396-01 1 VIAL in 1 CARTON (68382-396-01) > 50 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength10%;10% (5GM/50ML;5GM/50ML)
Approval Date:Aug 4, 2016TE:APRLD:No


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