FDA.reportPublic FDA data

Application 019658

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CLARITINLORATADINETABLET;ORAL10MGYesYes
003CLARITIN HIVES RELIEFLORATADINETABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-0007ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-0007ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-0007ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-0007ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-0007ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-1527ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-1527ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-1527ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4359ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4359ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-4359ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-6655ClaritinLoratadineBayer HealthCare LLCNDACurrent
11523-6655ClaritinLoratadineBayer HealthCare LLCNDACurrent
11523-6655ClaritinLoratadineBayer HealthCare LLCNDACurrent
11523-7160ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7160ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7160ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7237ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7237ClaritinLoratadineBayer HealthCare LLC.NDACurrent
11523-7237ClaritinLoratadineBayer HealthCare LLC.NDACurrent
52904-630ClaritinloratadineSelect CorporationNDACurrent
52904-630ClaritinloratadineSelect CorporationNDACurrent
66715-9732Lil Drug Store ClaritinLoratadineLil' Drug Store Products, IncNDACurrent
66715-9732Lil Drug Store ClaritinLoratadineLil' Drug Store Products, IncNDACurrent
66715-9732Lil Drug Store ClaritinLoratadineLil' Drug Store Products, IncNDACurrent
66715-9732Lil Drug Store ClaritinLoratadineLil' Drug Store Products, IncNDACurrent
67751-153ClaritinLORATADINENavajo Manufacturing Company Inc.NDACurrent
67751-153ClaritinloratadineNavajo Manufacturing CompanyNDACurrent
67751-153ClaritinLORATADINENavajo Manufacturing Company Inc.NDACurrent
67751-153ClaritinloratadineNavajo Manufacturing CompanyNDACurrent
70264-030ClaritinLoratadineR J General CorporationNDACurrent
70518-2951ClaritinLoratadineREMEDYREPACK INC.NDACurrent
70518-2951ClaritinLoratadineREMEDYREPACK INC.NDACurrent
73097-005ClaritinloratadineSavings Distributors LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82099SUPPL 2025-05-01
82020SUPPL 2025-04-28
57870SUPPL2019-03-01
57705SUPPL2019-02-20
57071SUPPL2018-12-31
57041SUPPL2018-12-27
55927SUPPL2018-10-15
55887SUPPL2018-10-11
54862SUPPL2018-07-06
54414SUPPL2018-06-01
54413SUPPL2018-06-01
54410SUPPL2018-06-01
54409SUPPL2018-06-01
48209SUPPL2017-05-02
48169SUPPL2017-05-01
46205SUPPL2016-12-19
46171SUPPL2016-12-15
45054SUPPL2016-08-22
45032SUPPL2016-08-09
11610SUPPL2015-12-22
1472SUPPL2015-12-22
33846SUPPL2013-09-18
17532SUPPL2008-01-09
40961SUPPL2007-03-02
40960SUPPL2007-03-02
20284SUPPL2004-12-07
1470SUPPL2003-11-25
1471SUPPL2003-07-06
17531SUPPL2002-11-27
20283SUPPL2001-05-25