RECORDATI RARE Application 212801

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISTURISA	OSILODROSTAT PHOSPHATE	TABLET;ORAL	EQ 1MG BASE	Yes	No
002	ISTURISA	OSILODROSTAT PHOSPHATE	TABLET;ORAL	EQ 5MG BASE	Yes	No
003	ISTURISA	OSILODROSTAT PHOSPHATE	TABLET;ORAL	EQ 10MG BASE	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55292-320	Isturisa	Osilodrostat	Recordati Rare Diseases, Inc.	NDA	Current
55292-320	Isturisa	Osilodrostat	Recordati Rare Diseases, Inc.	NDA	Current
55292-321	Isturisa	Osilodrostat	Recordati Rare Diseases, Inc.	NDA	Current
55292-321	Isturisa	Osilodrostat	Recordati Rare Diseases, Inc.	NDA	Current
55292-322	Isturisa	Osilodrostat	Recordati Rare Diseases, Inc.	NDA	Current
55292-322	Isturisa	Osilodrostat	Recordati Rare Diseases, Inc.	NDA	Current