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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 215025


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NDA 215025 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 six 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. Eight suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.
Summary for 215025
Pharmacology for NDA: 215025
Mechanism of ActionAmmonium Ion Binding Activity
Suppliers and Packaging for NDA: 215025
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 215025 NDA MAIA PHARMACEUTICALS 70511-102 70511-102-20 1 VIAL, SINGLE-DOSE in 1 CARTON (70511-102-20) / 20 mL in 1 VIAL, SINGLE-DOSE
SODIUM PHENYLACETATE AND SODIUM BENZOATE sodium benzoate; sodium phenylacetate SOLUTION;INTRAVENOUS 215025 NDA FOSUN PHARMA USA INC 72266-236 72266-236-01 1 VIAL, SINGLE-DOSE in 1 CARTON (72266-236-01) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10%;10% (2GM/20ML;2GM/20ML)
Approval Date:Jun 10, 2021TE:APRLD:Yes

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