Application 090135

Type: ANDA
Sponsor: GLENMARK GENERICS

Related Records

Company: GLENMARK GENERICS

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
50090-1822	ropinirole	ropinirole	A-S Medication Solutions	ANDA	Current
50090-1822	ropinirole	ropinirole	A-S Medication Solutions	ANDA	Current
50090-2068	ropinirole	ropinirole	A-S Medication Solutions	ANDA	Current
50090-2068	ropinirole	ropinirole	A-S Medication Solutions	ANDA	Current
50090-2068	ropinirole	ropinirole	A-S Medication Solutions	ANDA	Current
50090-2068	ropinirole	ropinirole	A-S Medication Solutions	ANDA	Current
50090-2068	ropinirole	ropinirole	A-S Medication Solutions	ANDA	Current
50090-4684	ropinirole	ropinirole	A-S Medication Solutions	ANDA	Current
50090-4684	ropinirole	ropinirole	A-S Medication Solutions	ANDA	Current
50090-4684	ropinirole	ropinirole	A-S Medication Solutions	ANDA	Current
50436-0255	ropinirole	ropinirole	Unit Dose Services	ANDA	Current
63629-6315	ropinirole	ropinirole	Bryant Ranch Prepack	ANDA	Current
68258-7163	ropinirole	ropinirole	Dispensing Solutions, Inc.	ANDA	Current
68462-253	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-253	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-253	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-253	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-253	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-253	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-254	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-254	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-254	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-254	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-254	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-254	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-255	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-255	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-255	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-255	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-255	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-255	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-256	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-256	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-256	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-256	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-256	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-256	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-257	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-257	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-257	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-257	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-257	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-257	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-258	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-258	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-258	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-258	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-258	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-258	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-259	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-259	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-259	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-259	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-259	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-259	ropinirole	ropinirole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70518-3478	ropinirole	ropinirole	REMEDYREPACK INC.	ANDA	Current
70518-3482	ropinirole	ropinirole	REMEDYREPACK INC.	ANDA	Current
70518-3482	ropinirole	ropinirole	REMEDYREPACK INC.	ANDA	Current
71335-0064	ropinirole	ropinirole	Bryant Ranch Prepack	ANDA	Current
71335-0064	ropinirole	ropinirole	Bryant Ranch Prepack	ANDA	Current
71335-0447	ropinirole	ropinirole	Bryant Ranch Prepack	ANDA	Current
71335-0560	ropinirole	ropinirole	Bryant Ranch Prepack	ANDA	Current
71335-0631	ropinirole	ropinirole	Bryant Ranch Prepack	ANDA	Current
71335-0631	ropinirole	ropinirole	Bryant Ranch Prepack	ANDA	Current