Application 090839

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	No	No
002	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	No	No
003	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	No	No
004	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	3MG	No	No
005	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	4MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3006	Risperidone	Risperidone	A-S Medication Solutions	ANDA	Current
50090-3006	Risperidone	Risperidone	A-S Medication Solutions	ANDA	Current
59746-010	Risperidone	Risperidone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-010	Risperidone	Risperidone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-020	Risperidone	Risperidone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-020	Risperidone	Risperidone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-030	Risperidone	Risperidone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-030	Risperidone	Risperidone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-040	Risperidone	Risperidone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-040	Risperidone	Risperidone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-050	Risperidone	Risperidone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-050	Risperidone	Risperidone	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current