Application 090429

Type: ANDA
Sponsor: ALEMBIC LTD

Related Records

Company: ALEMBIC LTD

Application Products

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	Labeler	Marketing category	Status
0615-8188	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8188	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8189	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8189	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8190	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8190	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8191	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8191	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6373	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6373	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6373	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6373	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6374	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6374	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6374	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-6374	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
21695-793	ropinirole hydrochloride	ropinirole hydrochloride	Rebel Distributors Corp	ANDA	Current
46708-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
50090-3304	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-3304	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-3304	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
53217-166	Ropinirole Hydrochloride	Ropinirole Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
55154-7633	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Cardinal Health 107, LLC	ANDA	Current
55154-7633	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-7888	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-7888	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Cardinal Health 107, LLC	ANDA	Current
55154-7888	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Cardinal Health	ANDA	Current
61919-564	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Direct_Rx	ANDA	Current
61919-780	ROPINIROLE	ROPINIROLE	Direct_Rx	ANDA	Current
61919-780	ROPINIROLE	ROPINIROLE	Direct_Rx	ANDA	Current
61919-780	ROPINIROLE	ROPINIROLE	Direct_Rx	ANDA	Current
62332-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-030	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-031	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-032	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-033	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-034	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-035	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-036	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
63629-4971	Ropinirole Hydrochloride	Ropinirole Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-4977	Ropinirole Hydrochloride	Ropinirole Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68258-7162	Ropinirole Hydrochloride	Ropinirole Hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
71335-0727	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0727	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0727	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0728	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0728	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current