Application 214860

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLPRUVA	SODIUM PHENYLBUTYRATE	SUSPENSION;ORAL	2G	Yes	No
002	OLPRUVA	SODIUM PHENYLBUTYRATE	SUSPENSION;ORAL	3G	Yes	No
003	OLPRUVA	SODIUM PHENYLBUTYRATE	SUSPENSION;ORAL	4G	Yes	No
004	OLPRUVA	SODIUM PHENYLBUTYRATE	SUSPENSION;ORAL	5G	Yes	No
005	OLPRUVA	SODIUM PHENYLBUTYRATE	SUSPENSION;ORAL	6G	Yes	No
006	OLPRUVA	SODIUM PHENYLBUTYRATE	SUSPENSION;ORAL	6.67G	Yes	No
007	OLPRUVA	SODIUM PHENYLBUTYRATE	FOR SUSPENSION;ORAL	0.5GM/PACKET	Yes	No
008	OLPRUVA	SODIUM PHENYLBUTYRATE	FOR SUSPENSION;ORAL	1GM/PACKET	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72542-200	OLPRUVA	sodium phenylbutyrate	Acer Therapeutics Inc.	NDA	Current
72542-300	OLPRUVA	sodium phenylbutyrate	Acer Therapeutics Inc.	NDA	Current
72542-400	OLPRUVA	sodium phenylbutyrate	Acer Therapeutics Inc.	NDA	Current
72542-500	OLPRUVA	sodium phenylbutyrate	Acer Therapeutics Inc.	NDA	Current
72542-600	OLPRUVA	sodium phenylbutyrate	Acer Therapeutics Inc.	NDA	Current
72542-667	OLPRUVA	sodium phenylbutyrate	Acer Therapeutics Inc.	NDA	Current