Last Updated: November 8, 2026

Details for New Drug Application (NDA): 220418

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NDA 220418 describes SODIUM PHENYLBUTYRATE, which is a drug marketed by Ph Health, Sigmapharm Labs Llc, Alvogen, Glenmark Pharms Ltd, and Navinta Llc, and is included in six NDAs. It is available from four suppliers. Additional details are available on the SODIUM PHENYLBUTYRATE profile page.

The generic ingredient in SODIUM PHENYLBUTYRATE is sodium phenylbutyrate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

Summary for 220418

Tradename:	SODIUM PHENYLBUTYRATE
Applicant:	Navinta Llc
Ingredient:	sodium phenylbutyrate
Patents:	0

Pharmacology for NDA: 220418

Mechanism of Action	Ammonium Ion Binding Activity

Suppliers and Packaging for NDA: 220418

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	220418	ANDA	Navinta LLC	68475-011	68475-011-01	1 BOTTLE in 1 CARTON (68475-011-01) / 250 TABLET in 1 BOTTLE
SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	220418	ANDA	Zydus Pharmaceuticals USA Inc.	70710-2180	70710-2180-8	1 BOTTLE in 1 CARTON (70710-2180-8) / 250 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Feb 17, 2026	TE:	AB	RLD:	No

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