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Last Updated: April 2, 2025

Suppliers and packagers for tradename: SODIUM PHENYLBUTYRATE

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SODIUM PHENYLBUTYRATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start

Endo Operations	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	POWDER;ORAL	203918	ANDA	ENDO USA, Inc.	49884-006-04	1 BOTTLE in 1 CARTON (49884-006-04) / 250 g in 1 BOTTLE	2016-08-31
Endo Operations	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	204395	ANDA	ENDO USA, Inc.	49884-170-04	1 BOTTLE in 1 CARTON (49884-170-04) / 250 TABLET in 1 BOTTLE	2016-04-29
Glenmark Pharms Ltd	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	216462	ANDA	GLENMARK PHARMACEUTICALS INC., USA	68462-853-20	250 TABLET in 1 BOTTLE (68462-853-20)	2022-11-01
Sigmapharm Labs Llc	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	POWDER;ORAL	202819	ANDA	Sigmapharm Laboratories, LLC	42794-086-14	1 BOTTLE in 1 CARTON (42794-086-14) / 250 g in 1 BOTTLE	2013-04-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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