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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078848
Company: ZYDUS LIFESCIENCES

Other Important Information from FDA

Products on ANDA 078848

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	No
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AB	No	No
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	AB	No	No
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078848

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2008	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/07/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/09/2018	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/21/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/12/2011	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078848

BENAZEPRIL HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076820	AMNEAL PHARMS
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076333	ANI PHARMS
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076402	CHARTWELL RX
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	077128	COREPHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076267	HERITAGE PHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076118	PRINSTON INC
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076344	SUN PHARM INDS LTD
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076211	TEVA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	078848	ZYDUS LIFESCIENCES

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	076820	AMNEAL PHARMS
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	076333	ANI PHARMS
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	078212	AUROBINDO PHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	076402	CHARTWELL RX
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	077128	COREPHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	076267	HERITAGE PHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	076118	PRINSTON INC
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	076344	SUN PHARM INDS LTD
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	076211	TEVA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	078848	ZYDUS LIFESCIENCES
LOTENSIN	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	Yes	AB	019851	VALIDUS PHARMS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	076820	AMNEAL PHARMS
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	076333	ANI PHARMS
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	078212	AUROBINDO PHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	076402	CHARTWELL RX
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	077128	COREPHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	076267	HERITAGE PHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	076118	PRINSTON INC
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	076344	SUN PHARM INDS LTD
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	076211	TEVA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	078848	ZYDUS LIFESCIENCES
LOTENSIN	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	Yes	AB	019851	VALIDUS PHARMS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	076820	AMNEAL PHARMS
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	076333	ANI PHARMS
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	078212	AUROBINDO PHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	076402	CHARTWELL RX
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	077128	COREPHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	076267	HERITAGE PHARMA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	076118	PRINSTON INC
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	076344	SUN PHARM INDS LTD
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	076211	TEVA
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	078848	ZYDUS LIFESCIENCES
LOTENSIN	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	Yes	AB	019851	VALIDUS PHARMS

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