Application 076288

Type: ANDA
Sponsor: MYLAN

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
0378-3502	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3502	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3502	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3505	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3505	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3505	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3511	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3511	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3511	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3512	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3512	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3512	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3513	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3513	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3513	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3514	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3514	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3514	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-7505	Risperidone	risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7506	Risperidone	risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7506	Risperidone	risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7507	Risperidone	risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7507	Risperidone	risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-754	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-755	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-757	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-766	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-460	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-461	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-462	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-462	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-463	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-463	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-463	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-464	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-464	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-464	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-465	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-465	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-465	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
53808-0624	Risperidone	risperidone	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0876	Risperidone	risperidone	State of Florida DOH Central Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44300	ORIG	2008-09-19

Application 076288

Related Records#

Application Products#

NDC Listings For This Application#

Documents#