FDA.reportPublic FDA data

Application 203045

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISENTRESSRALTEGRAVIR POTASSIUMTABLET, CHEWABLE;ORALEQ 25MG BASEYesNo
002ISENTRESSRALTEGRAVIR POTASSIUMTABLET, CHEWABLE;ORALEQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0473ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0477ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67558SUPPL2021-05-20
67554SUPPL2021-05-19
63956SUPPL2020-07-17
63941SUPPL2020-07-16
52912SUPPL2018-03-12
52828SUPPL2018-03-06
50504SUPPL2017-12-06
50475SUPPL2017-11-24
48598SUPPL2017-05-31
48578SUPPL2017-05-31
32360SUPPL2015-02-24
40253SUPPL2015-02-23
40252SUPPL2015-02-20
10150SUPPL2015-02-19
40251SUPPL2014-04-10
32359SUPPL2014-04-10
32358SUPPL2013-12-31
40250SUPPL2013-12-23
32357SUPPL2013-10-25
19413SUPPL2013-10-25
32356SUPPL2013-08-06
19412SUPPL2013-08-06
40249SUPPL2013-07-03
10148SUPPL2013-07-02
19411SUPPL2013-04-09
10149SUPPL2013-04-09
40248SUPPL2012-08-15
32355SUPPL2012-08-15
44874ORIG2012-04-30
22906ORIG2012-04-30
32354SUPPL2012-04-23
19410SUPPL2012-04-20
32353SUPPL2012-04-02
19409SUPPL2012-03-28
32352ORIG2011-12-27
19408ORIG2011-12-23