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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076631
Company: SANDOZ

Products on ANDA 076631

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	AB	No	No
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET;ORAL	Prescription	AB	No	No
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET;ORAL	Prescription	AB	No	No
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076631

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/11/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76631ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2020	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
11/03/2020	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
08/16/2018	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
03/24/2016	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
06/30/2015	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
09/23/2014	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
09/23/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/02/2011	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
07/28/2011	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/17/2010	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/28/2009	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/31/2009	SUPPL-9	Labeling		Label is not available on this site.
09/25/2007	SUPPL-7	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076631

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 5MG;6.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	076342	ANI PHARMS
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	078794	APOTEX
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	5MG;6.25MG	TABLET;ORAL	Prescription	No	AB	076631	SANDOZ

TABLET;ORAL; 10MG;12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET;ORAL	Prescription	No	AB	076342	ANI PHARMS
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET;ORAL	Prescription	No	AB	078794	APOTEX
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET;ORAL	Prescription	No	AB	076631	SANDOZ
LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET;ORAL	Prescription	Yes	AB	020033	VALIDUS PHARMS

TABLET;ORAL; 20MG;12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET;ORAL	Prescription	No	AB	076342	ANI PHARMS
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET;ORAL	Prescription	No	AB	078794	APOTEX
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET;ORAL	Prescription	No	AB	076631	SANDOZ
LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET;ORAL	Prescription	Yes	AB	020033	VALIDUS PHARMS

TABLET;ORAL; 20MG;25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET;ORAL	Prescription	No	AB	076342	ANI PHARMS
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET;ORAL	Prescription	No	AB	078794	APOTEX
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET;ORAL	Prescription	No	AB	076631	SANDOZ
LOTENSIN HCT	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	20MG;25MG	TABLET;ORAL	Prescription	Yes	AB	020033	VALIDUS PHARMS

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