Application 090411

Type: ANDA
Sponsor: CADILA

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
65841-712	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-712	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-712	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-712	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-713	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-713	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-713	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-713	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-714	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-714	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-714	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-714	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-715	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-715	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-715	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-715	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-716	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-716	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-716	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-716	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-717	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-717	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-717	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-717	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-718	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-718	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-718	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-718	ropinirole hydrochloride	ropinirole hydrochloride	Cadila Healthcare Limited	ANDA	Current
68382-338	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-338	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-339	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-339	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-340	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-340	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-341	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-341	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-342	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-342	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-343	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-343	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-344	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-344	ropinirole hydrochloride	ropinirole hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current

Application 090411

Related Records#

Application Products#

NDC Listings For This Application#