FDA.reportPublic FDA data

Application 022064

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XYZALLEVOCETIRIZINE DIHYDROCHLORIDETABLET;ORAL5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5803Xyzallevocetirizine dihydrochlorideSanofi-Aventis U.S. LLCNDACurrent
0024-5803Xyzallevocetirizine dihydrochlorideSanofi-Aventis U.S. LLCNDACurrent
0024-5803Xyzallevocetirizine dihydrochlorideSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82832SUPPL 2025-07-14
82828SUPPL 2025-07-14
58214SUPPL2019-04-04
58195SUPPL2019-04-03
57254SUPPL2019-01-18
57232SUPPL2019-01-16
53596SUPPL2018-04-03
53595SUPPL2018-04-03
50116SUPPL2017-10-19
50065SUPPL2017-10-17
48970SUPPL2017-07-13
48963SUPPL2017-07-13
47234SUPPL2017-02-16
47166SUPPL2017-02-10
45859SUPPL2016-11-09
45856SUPPL2016-11-09
38173SUPPL2016-06-27
29183SUPPL2016-06-24
38172SUPPL2013-11-08
6801SUPPL2013-11-08
38171SUPPL2012-09-11
6800SUPPL2012-09-07
6799SUPPL2011-03-10
16872SUPPL2011-03-07
6798SUPPL2009-11-10
38170SUPPL2009-10-06
52313ORIG2009-08-25
44671ORIG2008-10-15
42405ORIG2008-10-15
16869ORIG2008-04-09
6796ORIG2008-04-09
29182SUPPL2008-04-02
16871SUPPL2008-04-01
16870SUPPL2008-02-14
6797SUPPL2008-02-05
53311ORIG1900-01-01
53310ORIG1900-01-01