FDA.reportPublic FDA data

Application 019221

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VASERETICENALAPRIL MALEATE; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;25MGYesYes
003VASERETICENALAPRIL MALEATE; HYDROCHLOROTHIAZIDETABLET;ORAL5MG;12.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0146Vasereticenalapril maleate and hydrochlorothiazideBausch Health US LLCNDACurrent
0187-0146Vasereticenalapril maleate and hydrochlorothiazideBausch Health US LLCNDACurrent
0187-0146Vasereticenalapril maleate and hydrochlorothiazideBausch Health US LLCNDACurrent
0187-0146Vasereticenalapril maleate and hydrochlorothiazideBausch Health Americas, Inc.NDACurrent
0187-0146Vasereticenalapril maleate and hydrochlorothiazideBausch Health US LLCNDACurrent
0187-0146Vasereticenalapril maleate and hydrochlorothiazideValeant Pharmaceuticals North America LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64386SUPPL2020-08-24
64342SUPPL2020-08-21
49071SUPPL2017-07-25
49049SUPPL2017-07-25
17335SUPPL2015-08-27
11458SUPPL2015-08-26
11457SUPPL2015-01-09
1260SUPPL2014-12-30
17334SUPPL2012-09-17
33710SUPPL2012-09-14
17333SUPPL2012-02-23
33709SUPPL2012-02-22
1259SUPPL2011-03-16
11456SUPPL2011-03-14
1258SUPPL2008-09-29
1257SUPPL2007-11-08
1256SUPPL2002-10-30
40881SUPPL2001-11-27
11455SUPPL2001-11-27
1255SUPPL2001-11-27
40880SUPPL2001-06-22
20214SUPPL1998-10-13
40879SUPPL1997-06-11