Application 078888

Type: ANDA
Sponsor: ZYDUS PHARMS

Related Records

Company: ZYDUS PHARMS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	15MG	No	No
004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	TABLET;ORAL	7.5MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6899	Buspirone hydrochloride	Buspirone hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6899	Buspirone hydrochloride	Buspirone hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6899	Buspirone hydrochloride	Buspirone hydrochloride	Major Pharmaceuticals	ANDA	Current
50090-2111	Buspirone hydrochloride	Buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2111	Buspirone hydrochloride	Buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2111	Buspirone hydrochloride	Buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2111	Buspirone hydrochloride	Buspirone hydrochloride	A-S Medication Solutions	ANDA	Current
50268-135	Buspirone hydrochloride	Buspirone hydrochloride	AvPAK	ANDA	Current
50268-135	Buspirone hydrochloride	Buspirone hydrochloride	AvPAK	ANDA	Current
50268-135	Buspirone hydrochloride	Buspirone hydrochloride	AvPAK	ANDA	Current
50436-0182	Buspirone hydrochloride	Buspirone hydrochloride	Unit Dose Services	ANDA	Current
53217-276	Buspirone hydrochloride	Buspirone hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
55154-3364	Buspirone hydrochloride	Buspirone hydrochloride	Cardinal Health	ANDA	Current
55154-3364	Buspirone hydrochloride	Buspirone hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55700-433	Buspirone hydrochloride	Buspirone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-526	Buspirone hydrochloride	Buspirone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-526	Buspirone hydrochloride	Buspirone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-526	Buspirone hydrochloride	Buspirone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-526	Buspirone hydrochloride	Buspirone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-526	Buspirone hydrochloride	Buspirone hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-600	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	DirectRX	ANDA	Current
63629-6378	Buspirone hydrochloride	Buspirone hydrochloride	Bryant Ranch Prepack	ANDA	Current
65841-781	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-781	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-781	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-781	buspirone hydrochloride	buspirone hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-782	buspirone hydrochloride	buspirone hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-782	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-782	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-782	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-783	buspirone hydrochloride	buspirone hydrochloride	Zydus Lifesciences Limited	ANDA	Current
65841-783	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-783	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-783	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-784	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-784	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-784	buspirone hydrochloride	buspirone hydrochloride	Cadila Healthcare Limited	ANDA	Current
65841-784	buspirone hydrochloride	buspirone hydrochloride	Zydus Lifesciences Limited	ANDA	Current
66267-305	Buspirone hydrochloride	Buspirone hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-528	Buspirone hydrochloride	Buspirone hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-528	Buspirone hydrochloride	Buspirone hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-875	Buspirone hydrochloride	Buspirone hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-875	Buspirone hydrochloride	Buspirone hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
67296-1520	Buspirone hydrochloride	Buspirone hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1520	Buspirone hydrochloride	Buspirone hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1520	Buspirone hydrochloride	Buspirone hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68382-180	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-180	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-180	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-180	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-181	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-181	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-181	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-181	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-182	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-182	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-182	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-182	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-183	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-183	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-183	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-183	Buspirone hydrochloride	Buspirone hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68788-6878	Buspirone hydrochloride	Buspirone hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6878	Buspirone hydrochloride	Buspirone hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6878	Buspirone hydrochloride	Buspirone hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8929	Buspirone hydrochloride	Buspirone hydrochloride	PreferredPharmaceuticals Inc.	ANDA	Current
68788-8929	Buspirone hydrochloride	Buspirone hydrochloride	PreferredPharmaceuticals Inc.	ANDA	Current
68788-8929	Buspirone hydrochloride	Buspirone hydrochloride	PreferredPharmaceuticals Inc.	ANDA	Current
68788-8929	Buspirone hydrochloride	Buspirone hydrochloride	PreferredPharmaceuticals Inc.	ANDA	Current
68788-9766	Buspirone hydrochloride	Buspirone hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9766	Buspirone hydrochloride	Buspirone hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9766	Buspirone hydrochloride	Buspirone hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9766	Buspirone hydrochloride	Buspirone hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0380	Buspirone hydrochloride	Buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0380	Buspirone hydrochloride	Buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0380	Buspirone hydrochloride	Buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0380	Buspirone hydrochloride	Buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0380	Buspirone hydrochloride	Buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1050	Buspirone hydrochloride	Buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1050	Buspirone hydrochloride	Buspirone hydrochloride	REMEDYREPACK INC.	ANDA	Current