FDA.reportPublic FDA data

Application 021891

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S CLARITINLORATADINETABLET, CHEWABLE;ORAL5MGYesYes
002CLARITINLORATADINETABLET, CHEWABLE;ORAL10MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4328ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4330ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-4330ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-4330ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4331ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4364Claritin ChewableloratadineBayer HealthCare LLC.NDACurrent
11523-4364Claritin ChewableloratadineBayer HealthCare LLC.NDACurrent
11523-4364Claritin ChewableloratadineBayer HealthCare LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
86010SUPPL 2026-05-21
86006SUPPL 2026-05-21
85768SUPPL 2026-04-27
85761SUPPL 2026-04-27
82297SUPPL 2025-05-23
82103SUPPL 2025-05-01
82021SUPPL 2025-04-28
79692SUPPL 2024-09-23
79691SUPPL 2024-09-23
73070SUPPL2023-01-03
73059SUPPL2022-12-28
68142SUPPL2021-07-21
67210SUPPL2021-04-28
66991SUPPL2021-04-06
66479SUPPL2021-03-04
65870SUPPL2021-01-08
64244SUPPL2020-08-10
61234SUPPL2019-12-11
61233SUPPL2019-12-11
60247SUPPL2019-10-07
60246SUPPL2019-10-07
59109SUPPL2019-06-18
59108SUPPL2019-06-18
57121SUPPL2019-01-04
57118SUPPL2019-01-04
57053SUPPL2018-12-30
56723SUPPL2018-12-12
55110SUPPL2018-08-03
54945SUPPL2018-07-23
53020SUPPL2018-03-15
52696SUPPL2018-02-23
48536SUPPL2017-05-25
48524SUPPL2017-05-25
16527SUPPL2016-04-11
6396SUPPL2016-04-07
16526SUPPL2016-02-11
6395SUPPL2015-12-29
37833SUPPL2014-07-29
6394SUPPL2014-07-28
6393SUPPL2010-06-29
6392SUPPL2008-10-23
28790SUPPL2008-10-09
42340ORIG2008-07-09
28789ORIG2006-09-18
37832ORIG2006-09-15