FDA.reportPublic FDA data

Application 205786

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISENTRESSRALTEGRAVIR POTASSIUMPOWDER;ORALEQ 100MG BASE/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3603ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3603ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3603ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-3603ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-3603ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3603ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67559SUPPL2021-05-20
67555SUPPL2021-05-19
63958SUPPL2020-07-17
63942SUPPL2020-07-16
53011SUPPL2018-03-15
52827SUPPL2018-03-06
50506SUPPL2017-12-06
50476SUPPL2017-11-24
48597SUPPL2017-05-31
48577SUPPL2017-05-31
32726SUPPL2015-02-24
40504SUPPL2015-02-23
40503SUPPL2015-02-20
32725SUPPL2015-02-19
43503ORIG2014-06-27
24504ORIG2014-06-27
40502SUPPL2014-04-10
32724SUPPL2014-04-10
10502ORIG2013-12-31
40501ORIG2013-12-23
64577ORIG1900-01-01
63240SUPPL1900-01-01
63239SUPPL1900-01-01
51470ORIG1900-01-01
51469ORIG1900-01-01