FDA.reportPublic FDA data

Application 020033

Type
NDA
Sponsor
US PHARMS HOLDINGS I

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOTENSIN HCTBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002LOTENSIN HCTBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;12.5MGYesNo
003LOTENSIN HCTBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL20MG;25MGYesYes
004LOTENSIN HCTBENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDETABLET;ORAL20MG;12.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-0227benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePaddock Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0574-0227benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePadagis US LLCNDA AUTHORIZED GENERICCurrent
0574-0227benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePaddock Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0574-0227benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePadagis US LLCNDA AUTHORIZED GENERICCurrent
0574-0227benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePaddock Laboratories, LLC.NDA AUTHORIZED GENERICCurrent
0574-0228benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePadagis US LLCNDA AUTHORIZED GENERICCurrent
0574-0228benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePaddock Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0574-0228benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePaddock Laboratories, LLC.NDA AUTHORIZED GENERICCurrent
0574-0228benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePadagis US LLCNDA AUTHORIZED GENERICCurrent
0574-0228benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePaddock Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0574-0229benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePadagis US LLCNDA AUTHORIZED GENERICCurrent
0574-0229benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePaddock Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0574-0229benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePaddock Laboratories, LLC.NDA AUTHORIZED GENERICCurrent
0574-0229benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePadagis US LLCNDA AUTHORIZED GENERICCurrent
0574-0229benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazidePaddock Laboratories, LLCNDA AUTHORIZED GENERICCurrent
30698-452Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-452Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-452Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-452Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-453Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-453Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-453Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-453Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-454Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-454Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-454Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
30698-454Lotensin HCTbenazepril hydrochloride and hydrochlorothiazideValidus Pharmaceuticals LLCNDACurrent
64980-194benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
64980-194benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
64980-195benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
64980-195benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
64980-196benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
64980-196benazepril hydrochloride and hydrochlorothiazidebenazepril hydrochloride and hydrochlorothiazideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64352SUPPL2020-08-21
64338SUPPL2020-08-21
55413SUPPL2018-09-10
55160SUPPL2018-08-10
49265SUPPL2017-08-07
49253SUPPL2017-08-07
1935SUPPL2015-08-27
34198SUPPL2015-08-26
34197SUPPL2014-12-16
1934SUPPL2014-12-15
34196SUPPL2012-09-25
34195SUPPL2012-07-30
1933SUPPL2012-07-30
34194SUPPL2012-02-17
1932SUPPL2012-02-17
21063SUPPL2012-02-06
12151SUPPL2012-01-23
12150SUPPL2011-06-16
1931SUPPL2011-06-16
12149SUPPL2011-03-21
1930SUPPL2011-03-21
1929SUPPL2010-01-19
34193SUPPL2009-11-12
21062SUPPL2009-01-26
1928SUPPL2008-06-02
21061SUPPL2007-02-12
21060SUPPL2003-11-05