Details for New Drug Application (NDA): 205880

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 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 205880

Tradename:	SODIUM PHENYLACETATE AND SODIUM BENZOATE
Applicant:	Navinta Llc
Ingredient:	sodium benzoate; sodium phenylacetate
Patents:	0

Pharmacology for NDA: 205880

Mechanism of Action

Ammonium 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;INTRAVENOUS	205880	ANDA	Zydus Pharmaceuticals USA Inc.	68382-396	68382-396-01	1 VIAL in 1 CARTON (68382-396-01) / 50 mL in 1 VIAL
SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	205880	ANDA	Navinta LLC	68475-001	68475-001-50	1 VIAL in 1 CARTON (68475-001-50) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	10%;10% (5GM/50ML;5GM/50ML)
Approval Date:	Aug 4, 2016	TE:	AP	RLD:	No

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