Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078848
Company: ZYDUS PHARMS USA
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
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-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

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 077128 ANNORA PHARMA
BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 076402 CHARTWELL RX
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 PHARMS USA
LOTENSIN BENAZEPRIL HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 019851 VALIDUS PHARMS

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 077128 ANNORA PHARMA
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 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 PHARMS USA
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 077128 ANNORA PHARMA
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 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 PHARMS USA
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 077128 ANNORA PHARMA
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 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 PHARMS USA
LOTENSIN BENAZEPRIL HYDROCHLORIDE 40MG TABLET;ORAL Prescription Yes AB 019851 VALIDUS PHARMS

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