FDA.reportPublic FDA data

Application 020704

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CLARITIN REDITABSLORATADINETABLET, ORALLY DISINTEGRATING;ORAL10MGYesYes
003CLARITIN HIVES RELIEF REDITABLORATADINETABLET, ORALLY DISINTEGRATING;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-4329ClaritinLoratadineBayer Healthcare LLCNDACurrent
11523-4329ClaritinLoratadineBayer Healthcare LLC.NDACurrent
11523-4329ClaritinLoratadineBayer Healthcare LLC.NDACurrent
11523-4329ClaritinLoratadineBayer Healthcare LLC.NDACurrent
11523-4329ClaritinLoratadineBayer Healthcare LLC.NDACurrent
11523-7157ClaritinLoratadineBayer Healthcare LLCNDACurrent
11523-7157ClaritinLoratadineBayer Healthcare LLC.NDACurrent
11523-7157ClaritinLoratadineBayer Healthcare LLC.NDACurrent
11523-7157ClaritinLoratadineBayer Healthcare LLC.NDACurrent
11523-7157ClaritinLoratadineBayer Healthcare LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74406SUPPL 2023-05-30
74374SUPPL 2023-05-26
67531SUPPL2021-05-18
65899SUPPL2021-01-13
58629SUPPL2019-05-08
58628SUPPL2019-05-08
57866SUPPL2019-03-01
57856SUPPL2019-03-01
55108SUPPL2018-08-03
54972SUPPL2018-07-25
48465SUPPL2017-05-19
48457SUPPL2017-05-19
45900SUPPL2016-11-16
45837SUPPL2016-11-08
13250SUPPL2015-12-01
25580SUPPL2015-11-27
35180SUPPL2014-07-29
3139SUPPL2014-07-24
3138SUPPL2009-02-03
3137SUPPL2008-10-23
20858SUPPL2007-03-02
20857SUPPL2007-03-02
25579SUPPL2006-01-30
20859SUPPL2004-12-07
25578SUPPL2003-11-25
3136SUPPL2002-11-27