Application 091368

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Related Records

Company: ALEMBIC PHARMS LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.1MG	No	No
002	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.2MG	No	No
003	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	TABLET;ORAL	0.3MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-306	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-306	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-307	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-307	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-308	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-308	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
50090-2983	clonidine hydrochloride	Clonidine Hydrochloride	A-S Medication Solutions	ANDA	Current
52959-718	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	H. J. Harkins Company Inc.	ANDA	Current
53002-4140	clonidine hydrochloride	Clonidine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-4140	clonidine hydrochloride	Clonidine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-4940	clonidine hydrochloride	Clonidine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-4940	clonidine hydrochloride	Clonidine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
60760-057	clonidine hydrochloride	Clonidine Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-057	clonidine hydrochloride	Clonidine Hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-605	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	DirectRX	ANDA	Current
61919-605	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE	DirectRX	ANDA	Current
62332-054	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-054	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-054	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-055	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-055	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-055	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-056	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-056	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-056	clonidine hydrochloride	Clonidine Hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
66116-521	clonidine hydrochloride	Clonidine Hydrochloride	MedVantx, Inc.	ANDA	Current
68071-2210	clonidine hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2210	clonidine hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2210	clonidine hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3016	clonidine hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3016	clonidine hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3016	clonidine hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4041	clonidine hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4041	clonidine hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4041	clonidine hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4082	clonidine hydrochloride	Clonidine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7145	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7145	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7145	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7145	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7145	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7261	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7261	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7261	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8080	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8080	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8163	clonidine hydrochloride	Clonidine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1000	clonidine hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1000	clonidine hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1000	clonidine hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1000	clonidine hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1035	clonidine hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1035	clonidine hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1060	clonidine hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1060	clonidine hydrochloride	Clonidine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0777	clonidine hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0777	clonidine hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0777	clonidine hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0777	clonidine hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0915	clonidine hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0915	clonidine hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0915	clonidine hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0915	clonidine hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1495	clonidine hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1495	clonidine hydrochloride	Clonidine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72789-091	clonidine hydrochloride	Clonidine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-091	clonidine hydrochloride	Clonidine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-091	clonidine hydrochloride	Clonidine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-091	clonidine hydrochloride	Clonidine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-091	clonidine hydrochloride	Clonidine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-091	clonidine hydrochloride	Clonidine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-091	clonidine hydrochloride	Clonidine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76420-066	clonidine hydrochloride	Clonidine Hydrochloride	Asclemed USA, Inc.	ANDA	Current