FDA.reportPublic FDA data

Application 021313

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLARINEX-D 12 HOURDESLORATADINE; PSEUDOEPHEDRINE SULFATETABLET, EXTENDED RELEASE;ORAL2.5MG;120MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1322CLARINEX-D 12 HOURdesloratadine and pseudoephedrine sulfateMerck Sharp & Dohme Corp.NDACurrent
0085-1322CLARINEX-D 12 HOURdesloratadine and pseudoephedrine sulfateMerck Sharp & Dohme Corp.NDACurrent
0085-1322CLARINEX-D 12 HOURdesloratadine and pseudoephedrine sulfateMerck Sharp & Dohme Corp.NDACurrent
78206-120CLARINEX-D 12 HOURdesloratadine and pseudoephedrine sulfateOrganon LLCNDACurrent
78206-120CLARINEX-D 12 HOURdesloratadine and pseudoephedrine sulfateOrganon LLCNDACurrent
78206-120CLARINEX-D 12 HOURdesloratadine and pseudoephedrine sulfateOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58023SUPPL2019-03-18
58017SUPPL2019-03-18
53780SUPPL2018-04-23
53750SUPPL2018-04-20
52515SUPPL2018-02-08
52500SUPPL2018-02-07
36636SUPPL2014-03-10
27456SUPPL2014-03-10
36635SUPPL2010-01-12
5003SUPPL2010-01-05
42093ORIG2008-07-09
15167SUPPL2007-07-24
5002SUPPL2007-07-24
27455ORIG2006-02-08
15166ORIG2006-02-07