Last Updated: July 27, 2026

Details for New Drug Application (NDA): 202819

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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 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 202819

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

Profile for product number 001

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

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