FDA.reportPublic FDA data

Application 021952

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLARITINLORATADINECAPSULE;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-7200ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7200ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7200ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7200ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7200ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7333ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7333ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7333ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7333ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7333ClaritinLoratadineBayer HealthCare LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85763SUPPL 2026-04-27
85762SUPPL 2026-04-27
74417SUPPL 2023-06-01
74416SUPPL 2023-06-01
57072SUPPL2018-12-31
57042SUPPL2018-12-27
55109SUPPL2018-08-03
54948SUPPL2018-07-23
54744SUPPL2018-07-04
54700SUPPL2018-06-27
54465SUPPL2018-06-06
54439SUPPL2018-06-05
53790SUPPL2018-04-23
53775SUPPL2018-04-23
37943SUPPL2015-12-11
6535SUPPL2015-12-10
42358ORIG2009-08-27
6534SUPPL2009-04-10
24229ORIG2008-07-17
6533ORIG2008-06-19