RECORDATI RARE Application 010841

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEGANONE	ETHOTOIN	TABLET;ORAL	250MG	Yes	Yes
003	PEGANONE	ETHOTOIN	TABLET;ORAL	500MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55292-602	Peganone	ethotoin	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-602	Peganone	ethotoin	RECORDATI RARE DISEASES, INC.	NDA	Current