Last Updated: November 8, 2026

Details for New Drug Application (NDA): 202819

NDA 202819 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 202819

Tradename:	SODIUM PHENYLBUTYRATE
Applicant:	Sigmapharm Labs Llc
Ingredient:	sodium phenylbutyrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;ORAL			Strength	3GM/TEASPOONFUL
Approval Date:	Mar 22, 2013	TE:		RLD:	No

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