Application 078040

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERIDONE	RISPERIDONE	TABLET;ORAL	0.25MG	No	No
002	RISPERIDONE	RISPERIDONE	TABLET;ORAL	0.5MG	No	No
003	RISPERIDONE	RISPERIDONE	TABLET;ORAL	1MG	No	No
004	RISPERIDONE	RISPERIDONE	TABLET;ORAL	2MG	No	No
005	RISPERIDONE	RISPERIDONE	TABLET;ORAL	3MG	No	No
006	RISPERIDONE	RISPERIDONE	TABLET;ORAL	4MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3777	risperidone	risperidone	A-S Medication Solutions	ANDA	Current
50268-695	risperidone	risperidone	AvPAK	ANDA	Current
50268-695	risperidone	risperidone	AvPAK	ANDA	Current
50268-696	risperidone	risperidone	AvPAK	ANDA	Current
50268-696	risperidone	risperidone	AvPAK	ANDA	Current
50268-697	risperidone	risperidone	AvPAK	ANDA	Current
50268-697	risperidone	risperidone	AvPAK	ANDA	Current
50268-698	risperidone	risperidone	AvPAK	ANDA	Current
50268-698	risperidone	risperidone	AvPAK	ANDA	Current
50268-699	risperidone	risperidone	AvPAK	ANDA	Current
50268-699	risperidone	risperidone	AvPAK	ANDA	Current
53808-0683	risperidone	risperidone	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0890	risperidone	risperidone	State of Florida DOH Central Pharmacy	ANDA	Current
53808-1021	risperidone	risperidone	State of Florida DOH Central Pharmacy	ANDA	Current
55700-017	risperidone	risperidone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-082	risperidone	risperidone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-082	risperidone	risperidone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-082	risperidone	risperidone	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
58118-0077	risperidone	risperidone	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0077	risperidone	risperidone	Clinical Solutions Wholesale, LLC	ANDA	Current
58118-0077	risperidone	risperidone	Clinical Solutions Wholesale, LLC	ANDA	Current
61919-572	RISPERIDONE	RISPERIDONE	DIRECT RX	ANDA	Current
61919-572	RISPERIDONE	RISPERIDONE	DIRECT RX	ANDA	Current
63187-418	risperidone	risperidone	Proficient Rx LP	ANDA	Current
63187-418	risperidone	risperidone	Proficient Rx LP	ANDA	Current
64725-0113	risperidone	risperidone	TYA Pharmaceuticals	ANDA	Current
64725-0114	risperidone	risperidone	TYA Pharmaceuticals	ANDA	Current
65841-665	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-665	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-665	risperidone	risperidone	Zydus Lifesciences Limited	ANDA	Current
65841-666	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-666	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-666	risperidone	risperidone	Zydus Lifesciences Limited	ANDA	Current
65841-667	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-667	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-667	risperidone	risperidone	Zydus Lifesciences Limited	ANDA	Current
65841-668	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-668	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-668	risperidone	risperidone	Zydus Lifesciences Limited	ANDA	Current
65841-669	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-669	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-669	risperidone	risperidone	Zydus Lifesciences Limited	ANDA	Current
65841-670	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-670	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-670	risperidone	risperidone	Zydus Lifesciences Limited	ANDA	Current
67046-653	Risperidone	Risperidone	Contract Pharmacy Services-PA	ANDA	Current
67046-654	Risperidone	Risperidone	Contract Pharmacy Services-PA	ANDA	Current
67046-655	Risperidone	Risperidone	Contract Pharmacy Services-PA	ANDA	Current
67046-656	Risperidone	Risperidone	Contract Pharmacy Services-PA	ANDA	Current
67046-657	Risperidone	Risperidone	Contract Pharmacy Services-PA	ANDA	Current
67046-658	Risperidone	Risperidone	Contract Pharmacy Services-PA	ANDA	Current
68071-2138	risperidone	risperidone	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3369	risperidone	risperidone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-270	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-270	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-270	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-270	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-271	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-271	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-271	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-271	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-272	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-272	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-272	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-272	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-273	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-273	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-273	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-273	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-274	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-274	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-274	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-274	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-277	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-277	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-277	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68084-277	Risperidone	Risperidone	American Health Packaging	ANDA	Current
68382-112	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-112	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-112	risperidone	risperidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current

Application 078040

Related Records#

Application Products#

NDC Listings For This Application#