FDA.reportPublic FDA data

Application 019670

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CLARITIN-DLORATADINE; PSEUDOEPHEDRINE SULFATETABLET, EXTENDED RELEASE;ORAL5MG;120MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-7162Claritin-DLoratadine and pseudoephedrine sulfateBayer HealthCare LLC.NDACurrent
11523-7162Claritin-DLoratadine and pseudoephedrine sulfateBayer HealthCare LLC.NDACurrent
11523-7162Claritin-DLoratadine and pseudoephedrine sulfateBayer HealthCare LLC.NDACurrent
11523-7162Claritin-DLoratadine and pseudoephedrine sulfateBayer HealthCare LLC.NDACurrent
70518-3566Claritin-DLoratadine and pseudoephedrine sulfateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76612SUPPL 2023-11-17
76559SUPPL 2023-11-14
55113SUPPL2018-08-03
55090SUPPL2018-08-03
11619SUPPL2015-12-11
1485SUPPL2015-11-27
40969SUPPL2011-12-16
1484SUPPL2010-02-17
1483SUPPL2009-04-27
40967SUPPL2007-03-02
40966SUPPL2007-03-02
40965SUPPL2007-03-02
40964SUPPL2007-03-02
40963SUPPL2007-03-02
20286SUPPL2007-03-02
20285SUPPL2007-03-02
40968SUPPL2004-12-07
17543SUPPL2004-08-02
11618SUPPL2004-08-02
17542SUPPL2002-11-27