Application 207231

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	1MG	No	No
002	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	2MG	No	No
003	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	4MG	No	No
004	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	6MG	No	No
005	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	8MG	No	No
006	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	10MG	No	No
007	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	12MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0630	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0630	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0631	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0631	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0632	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0632	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0633	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0633	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0634	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0634	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0635	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0635	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0636	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0636	Iloperidone	Iloperidone	Mylan Pharmaceuticals Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
74046	ORIG	2023-04-24
45970	ORIG	2016-11-30