Application 078881

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 0.25MG BASE	No	No
002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 0.5MG BASE	No	No
003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE	No	No
004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 2MG BASE	No	No
005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 3MG BASE	No	No
006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 4MG BASE	No	No
007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5501	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5501	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5501	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5501	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5501	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5501	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5501	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5502	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5502	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5502	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5502	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5502	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5502	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5502	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5503	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5503	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5503	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5503	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5503	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5503	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5503	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5504	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5504	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5504	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5504	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5504	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5504	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5504	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5505	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5505	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5505	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5505	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5505	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5505	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5505	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5525	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5525	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5525	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5525	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5525	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5525	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5525	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5550	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5550	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5550	Ropinirole Hydrochloride	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5550	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5550	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5550	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5550	Ropinirole	ropinirole	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-7536	Ropinirole Hydrochloride	Ropinirole Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7537	Ropinirole Hydrochloride	Ropinirole Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7538	Ropinirole Hydrochloride	Ropinirole Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7539	Ropinirole Hydrochloride	Ropinirole Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7567	Ropinirole Hydrochloride	Ropinirole Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-258	Ropinirole Hydrochloride	ropinirole	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-265	Ropinirole Hydrochloride	ropinirole	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-266	Ropinirole Hydrochloride	ropinirole	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-267	Ropinirole Hydrochloride	ropinirole	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
60429-817	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-817	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply	ANDA	Current
60429-817	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-817	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-818	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-818	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply	ANDA	Current
60429-818	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-818	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-819	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-819	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-819	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply	ANDA	Current
60429-819	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-820	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-820	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply	ANDA	Current
60429-820	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-820	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-821	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-821	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-821	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply	ANDA	Current
60429-821	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-822	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply, Inc.	ANDA	Current
60429-822	Ropinirole Hydrochloride	ropinirole	Golden State Medical Supply	ANDA	Current

Application 078881

Related Records#

Application Products#

NDC Listings For This Application#