Application 201003

Type: ANDA
Sponsor: AJANTA PHARMA LTD

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
27241-001	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-001	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-001	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-001	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-001	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-002	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-002	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-002	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-002	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-002	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-003	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-003	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-003	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-003	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-003	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-004	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-004	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-004	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-004	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-004	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-005	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-005	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-005	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-005	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-005	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-006	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-006	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-006	RISPERIDONE	RISPERIDONE	Ajanta Pharma Limited	ANDA	Current
27241-006	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
27241-006	RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	ANDA	Current
42495-004	RISPERIDONE	RISPERIDONE	MSM Repackaging	ANDA	Current
43063-908	RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-908	RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-908	RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-908	RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-908	RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-908	RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-908	RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-908	RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-3340	RISPERIDONE	RISPERIDONE	A-S Medication Solutions	ANDA	Current
50090-3340	RISPERIDONE	RISPERIDONE	A-S Medication Solutions	ANDA	Current
50090-3341	RISPERIDONE	RISPERIDONE	A-S Medication Solutions	ANDA	Current
50090-3341	RISPERIDONE	RISPERIDONE	A-S Medication Solutions	ANDA	Current
50090-3341	RISPERIDONE	RISPERIDONE	A-S Medication Solutions	ANDA	Current
50090-3344	RISPERIDONE	RISPERIDONE	A-S Medication Solutions	ANDA	Current
50090-3344	RISPERIDONE	RISPERIDONE	A-S Medication Solutions	ANDA	Current
53808-1022	RISPERIDONE	RISPERIDONE	State of Florida DOH Central Pharmacy	ANDA	Current
55700-392	RISPERIDONE	RISPERIDONE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-897	RISPERIDONE	RISPERIDONE	Quality Care Products, LLC	ANDA	Current
55700-897	RISPERIDONE	RISPERIDONE	Quality Care Products, LLC	ANDA	Current
63187-264	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
63187-264	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
63187-264	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
63187-439	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
63187-439	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
63187-439	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
63187-642	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
63187-642	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
63187-642	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
63629-8121	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
64725-0319	RISPERIDONE	RISPERIDONE	TYA Pharmaceuticals	ANDA	Current
64725-0321	RISPERIDONE	RISPERIDONE	TYA Pharmaceuticals	ANDA	Current
68071-2524	RISPERIDONE	RISPERIDONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2706	RISPERIDONE	RISPERIDONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3356	RISPERIDONE	RISPERIDONE	Nucare Pharmaceuticals,Inc.	ANDA	Current
68071-4618	RISPERIDONE	RISPERIDONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4618	RISPERIDONE	RISPERIDONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7211	RISPERIDONE	RISPERIDONE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7211	RISPERIDONE	RISPERIDONE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7211	RISPERIDONE	RISPERIDONE	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0364	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-0364	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-0364	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-0364	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-0364	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-0364	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-0364	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-0364	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-0364	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1502	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current

Application 201003

Related Records#

Application Products#

NDC Listings For This Application#