FDA.reportPublic FDA data

Application 020641

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CLARITINLORATADINESYRUP;ORAL1MG/MLYesYes
003CLARITIN HIVES RELIEFLORATADINESYRUP;ORAL1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-4360Children ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-4360Children ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-4360Children ClaritinloratadineBayer HealthCare LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80586SUPPL 2024-12-16
80585SUPPL 2024-12-16
57865SUPPL2019-03-01
57855SUPPL2019-03-01
54314SUPPL2018-05-23
54218SUPPL2018-05-16
45089SUPPL2016-08-22
45033SUPPL2016-08-09
12919SUPPL2016-01-04
2992SUPPL2015-12-31
35067SUPPL2015-11-25
2991SUPPL2015-11-09
35066SUPPL2015-10-26
25433SUPPL2015-10-23
2990SUPPL2015-04-22
12918SUPPL2015-04-21
35065SUPPL2014-01-14
2989SUPPL2013-03-01
25432SUPPL2008-07-30
25431SUPPL2008-07-30
41517SUPPL2007-03-02
20803SUPPL2007-03-02
2988SUPPL2005-06-15
41518SUPPL2004-12-07
2987SUPPL2004-10-29
25430SUPPL2004-07-21
25429SUPPL2003-11-25
25428SUPPL2002-11-27
20804SUPPL2000-12-04
12917SUPPL2000-12-04
2986SUPPL2000-12-04