FDA.reportPublic FDA data

Application 019851

Type
NDA
Sponsor
US PHARMS HOLDINGS I

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOTENSINBENAZEPRIL HYDROCHLORIDETABLET;ORAL5MGYesNo
002LOTENSINBENAZEPRIL HYDROCHLORIDETABLET;ORAL10MGYesNo
003LOTENSINBENAZEPRIL HYDROCHLORIDETABLET;ORAL20MGYesNo
004LOTENSINBENAZEPRIL HYDROCHLORIDETABLET;ORAL40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30698-448Lotensinbenazepril hydrochlorideValidus Pharmaceuticals LLCNDACurrent
30698-448Lotensinbenazepril hydrochlorideValidus Pharmaceuticals LLCNDACurrent
30698-448Lotensinbenazepril hydrochlorideValidus Pharmaceuticals LLCNDACurrent
30698-449Lotensinbenazepril hydrochlorideValidus Pharmaceuticals LLCNDACurrent
30698-449Lotensinbenazepril hydrochlorideValidus Pharmaceuticals LLCNDACurrent
30698-449Lotensinbenazepril hydrochlorideValidus Pharmaceuticals LLCNDACurrent
30698-450Lotensinbenazepril hydrochlorideValidus Pharmaceuticals LLCNDACurrent
30698-450Lotensinbenazepril hydrochlorideValidus Pharmaceuticals LLCNDACurrent
30698-450Lotensinbenazepril hydrochlorideValidus Pharmaceuticals LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57433SUPPL2019-02-04
57159SUPPL2019-01-09
49266SUPPL2017-08-07
49252SUPPL2017-08-07
34035SUPPL2015-07-24
11780SUPPL2015-07-24
19759SUPPL2015-07-23
1712SUPPL2015-07-23
34034SUPPL2015-01-30
19758SUPPL2015-01-27
34033SUPPL2014-12-16
19757SUPPL2014-12-15
34032SUPPL2012-09-25
34030SUPPL2012-05-22
19755SUPPL2012-05-21
19756SUPPL2012-02-06
34031SUPPL2012-01-23
11779SUPPL2011-06-16
1711SUPPL2011-06-16
1710SUPPL2010-01-07
34029SUPPL2009-11-16
19754SUPPL2009-01-26
1709SUPPL2008-06-02
1708SUPPL2007-02-12
44037ORIG2006-06-09
11778SUPPL2004-04-05
1706SUPPL2004-03-03
1707SUPPL2003-11-05
51783ORIG1900-01-01
51782ORIG1900-01-01
51781ORIG1900-01-01
51780ORIG1900-01-01
51779ORIG1900-01-01