FDA.reportPublic FDA data

Application 020470

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CLARITIN-D 24 HOURLORATADINE; PSEUDOEPHEDRINE SULFATETABLET, EXTENDED RELEASE;ORAL10MG;240MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-4332Claritin-DLoratadine and pseudoephedrine sulfateBayer HealthCare LLC.NDACurrent
11523-4332Claritin-DLoratadine and pseudoephedrine sulfateBayer HealthCare LLC.NDACurrent
11523-4332Claritin-DLoratadine and pseudoephedrine sulfateBayer HealthCare LLC.NDACurrent
11523-4332Claritin-DLoratadine and pseudoephedrine sulfateBayer HealthCare LLC.NDACurrent
11523-4332Claritin-DLoratadine and pseudoephedrine sulfateBayer HealthCare LLC.NDACurrent
70518-2761Claritin-DLoratadine and pseudoephedrine sulfateREMEDYREPACK INC.NDACurrent
70518-2761Claritin-DLoratadine and pseudoephedrine sulfateREMEDYREPACK INC.NDACurrent
70518-2761Claritin-DLoratadine and pseudoephedrine sulfateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76611SUPPL 2023-11-17
76560SUPPL 2023-11-14
55114SUPPL2018-08-03
55091SUPPL2018-08-03
34681SUPPL2015-12-11
25008SUPPL2015-11-27
25007SUPPL2010-02-17
41382SUPPL2007-03-02
41381SUPPL2007-03-02
20669SUPPL2007-03-02
41383SUPPL2004-12-07
25006SUPPL2004-08-02
12614SUPPL2004-08-02
2572SUPPL2004-07-21
25005SUPPL2003-07-06
25004SUPPL2002-11-27
41380SUPPL1998-12-04