Details for New Drug Application (NDA): 208521

NDA 208521 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 208521

Tradename:	SODIUM PHENYLACETATE AND SODIUM BENZOATE
Applicant:	Maia Pharms Inc
Ingredient:	sodium benzoate; sodium phenylacetate
Patents:	0

Pharmacology for NDA: 208521

Mechanism of Action

Ammonium Ion Binding Activity

Suppliers and Packaging for NDA: 208521

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	208521	ANDA	MAIA PHARMACEUTICALS, INC	70511-101	70511-101-50	1 VIAL, SINGLE-DOSE in 1 CARTON (70511-101-50) / 50 mL in 1 VIAL, SINGLE-DOSE
SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	208521	ANDA	FOSUN PHARMA USA INC	72266-247	72266-247-01	1 VIAL, SINGLE-DOSE in 1 CARTON (72266-247-01) / 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	10%;10% (5GM/50ML;5GM/50ML)
Approval Date:	May 8, 2017	TE:	AP	RLD:	No

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