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Last Updated: November 14, 2024

Details for New Drug Application (NDA): 090910

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NDA 090910 describes SODIUM PHENYLBUTYRATE, which is a drug marketed by Endo Operations, Sigmapharm Labs Llc, Alvogen, and Glenmark Pharms Ltd, and is included in five NDAs. It is available from three 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. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

Summary for 090910

Tradename:	SODIUM PHENYLBUTYRATE
Applicant:	Alvogen
Ingredient:	sodium phenylbutyrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Nov 18, 2011	TE:		RLD:	No

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