Application 077493

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERIDONE	RISPERIDONE	TABLET;ORAL	0.25MG	No	No
002	RISPERIDONE	RISPERIDONE	TABLET;ORAL	0.5MG	No	No
003	RISPERIDONE	RISPERIDONE	TABLET;ORAL	1MG	No	No
004	RISPERIDONE	RISPERIDONE	TABLET;ORAL	2MG	No	No
005	RISPERIDONE	RISPERIDONE	TABLET;ORAL	3MG	No	No
006	RISPERIDONE	RISPERIDONE	TABLET;ORAL	4MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8196	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8196	Risperidone	Risperidone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8196	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8197	Risperidone	Risperidone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8197	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8197	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8198	Risperidone	Risperidone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8198	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8198	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8265	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8265	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8265	Risperidone	Risperidone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8288	Risperidone	Risperidone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8288	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43547-339	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-339	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-339	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-339	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-340	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-340	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-340	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-340	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-341	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-341	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-341	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-341	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-342	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-342	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-342	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-342	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-343	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-343	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-343	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-343	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-344	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-344	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-344	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-344	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
70518-2969	Risperidone	Risperidone	REMEDYREPACK INC.	ANDA	Current
70518-2969	Risperidone	Risperidone	REMEDYREPACK INC.	ANDA	Current
71610-259	Risperidone	Risperidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Application 077493

Related Records#

Application Products#

NDC Listings For This Application#