Last Updated: May 25, 2026

Details for New Drug Application (NDA): 203918

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NDA 203918 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 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 phenylbutyrate profile page.

Summary for 203918

Tradename:	SODIUM PHENYLBUTYRATE
Applicant:	Ph Health
Ingredient:	sodium phenylbutyrate
Patents:	0

Pharmacology for NDA: 203918

Mechanism of Action	Ammonium Ion Binding Activity

Suppliers and Packaging for NDA: 203918

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	POWDER;ORAL	203918	ANDA	Par Health USA, LLC	49884-006	49884-006-04	1 BOTTLE in 1 CARTON (49884-006-04) / 250 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	3GM/TEASPOONFUL
Approval Date:	Jun 15, 2016	TE:	AB	RLD:	No

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