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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 217526


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NDA 217526 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 five NDAs. It is available from seven 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 seventy-two 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 217526
Tradename:SODIUM PHENYLACETATE AND SODIUM BENZOATE
Applicant:Navinta Llc
Ingredient:sodium benzoate; sodium phenylacetate
Patents:0
Pharmacology for NDA: 217526
Mechanism of ActionAmmonium Ion Binding Activity
Suppliers and Packaging for NDA: 217526
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM PHENYLACETATE AND SODIUM BENZOATE sodium benzoate; sodium phenylacetate SOLUTION;INTRAVENOUS 217526 ANDA Navinta LLC 68475-513 68475-513-01 1 VIAL in 1 CARTON (68475-513-01) / 20 mL in 1 VIAL
SODIUM PHENYLACETATE AND SODIUM BENZOATE sodium benzoate; sodium phenylacetate SOLUTION;INTRAVENOUS 217526 ANDA Zydus Pharmaceuticals USA Inc. 70710-1926 70710-1926-1 1 VIAL in 1 CARTON (70710-1926-1) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10%;10% (2GM/20ML; 2GM/20ML)
Approval Date:Jul 14, 2023TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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