Application 078212

Type: ANDA
Sponsor: AUROBINDO PHARMA

Related Records

Company: AUROBINDO PHARMA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	20MG	No	No
003	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	TABLET;ORAL	40MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-748	Benazepril Hydrochloride	Benazepril Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-748	Benazepril Hydrochloride	Benazepril Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-748	Benazepril Hydrochloride	Benazepril Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-748	Benazepril Hydrochloride	Benazepril Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-748	Benazepril Hydrochloride	Benazepril Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-748	Benazepril Hydrochloride	Benazepril Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-3359	Benazepril Hydrochloride	Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3359	Benazepril Hydrochloride	Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5750	Benazepril Hydrochloride	Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5751	Benazepril Hydrochloride	Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5751	Benazepril Hydrochloride	Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
65862-116	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-116	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-116	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-116	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-117	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-117	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-117	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-117	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-118	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-118	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-118	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-118	Benazepril Hydrochloride	Benazepril Hydrochloride	Aurobindo Pharma Limited	ANDA	Current
68071-4722	Benazepril Hydrochloride	Benazepril Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4722	Benazepril Hydrochloride	Benazepril Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4722	Benazepril Hydrochloride	Benazepril Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4890	Benazepril Hydrochloride	Benazepril Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4890	Benazepril Hydrochloride	Benazepril Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5028	Benazepril Hydrochloride	Benazepril Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5028	Benazepril Hydrochloride	Benazepril Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7248	Benazepril Hydrochloride	Benazepril Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7248	Benazepril Hydrochloride	Benazepril Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7845	Benazepril Hydrochloride	Benazepril Hydrochloride	Preferred Pharmaceuticlas Inc.	ANDA	Current
68788-7845	Benazepril Hydrochloride	Benazepril Hydrochloride	Preferred Pharmaceuticlas Inc.	ANDA	Current
68788-7845	Benazepril Hydrochloride	Benazepril Hydrochloride	Preferred Pharmaceuticlas Inc.	ANDA	Current
68788-7846	Benazepril Hydrochloride	Benazepril Hydrochloride	Preferred Pharmaceuticlas Inc.	ANDA	Current
70518-3074	Benazepril Hydrochloride	Benazepril Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3171	Benazepril Hydrochloride	Benazepril Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3172	Benazepril Hydrochloride	Benazepril Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-983	Benazepril Hydrochloride	Benazepril Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-983	Benazepril Hydrochloride	Benazepril Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-320	Benazepril Hydrochloride	Benazepril Hydrochloride	Proficient Rx LP	ANDA	Current
71335-1365	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1365	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1365	Benazepril Hydrochloride	Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents

Document	Submission type	Date
44378	ORIG	2008-05-30