FDA.reportPublic FDA data

Application 076631

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL5MG;6.25MGNoNo
002BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;12.5MGNoNo
003BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL20MG;12.5MGNoNo
004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL20MG;25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0211Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0211Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0211Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0211Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0236Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0236Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0236Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0236Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0277Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0277Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0277Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0277Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0325Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0325Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0325Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0185-0325Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideEon Labs, Inc.ANDACurrent
0832-0483Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideUpsher-Smith Laboratories, LLCANDACurrent
0832-0483Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideUpsher-Smith Laboratories, LLCANDACurrent
0832-0484Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideUpsher-Smith Laboratories, LLCANDACurrent
0832-0484Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideUpsher-Smith Laboratories, LLCANDACurrent
0832-0485Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideUpsher-Smith Laboratories, LLCANDACurrent
0832-0485Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideUpsher-Smith Laboratories, LLCANDACurrent
52959-595Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideH.J. Harkins Company, Inc.ANDACurrent
63629-1809Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2680Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2680Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2680Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and HydrochlorothiazideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8936ORIG2004-02-12