FDA.reportPublic FDA data

Application 022145

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISENTRESSRALTEGRAVIR POTASSIUMTABLET;ORALEQ 400MG BASEYesYes
002ISENTRESS HDRALTEGRAVIR POTASSIUMTABLET;ORALEQ 600MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0227ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0227ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-0227ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-0227ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0227ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-0227ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3080ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3080ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3080ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-3080ISENTRESSRALTEGRAVIRMerck Sharp & Dohme LLCNDACurrent
0006-3080ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3080ISENTRESSRALTEGRAVIRMerck Sharp & Dohme Corp.NDACurrent
50090-1085ISENTRESSRALTEGRAVIRA-S Medication SolutionsNDACurrent
50090-1085ISENTRESSRALTEGRAVIRA-S Medication SolutionsNDACurrent
50090-1085ISENTRESSRALTEGRAVIRA-S Medication SolutionsNDACurrent
50090-1085ISENTRESSRALTEGRAVIRA-S Medication SolutionsNDACurrent
50090-1085ISENTRESSRALTEGRAVIRA-S Medication SolutionsNDACurrent
53808-0650ISENTRESSraltegravirState of Florida DOH Central PharmacyNDACurrent
61919-706ISENTRESSISENTRESSDIRECT RXNDACurrent
61919-706ISENTRESSISENTRESSDIRECT RXNDACurrent
61919-706ISENTRESSISENTRESSDIRECT RXNDACurrent
61919-706ISENTRESSISENTRESSDirect_RxNDACurrent
61919-706ISENTRESSISENTRESSDirect_RxNDACurrent
61919-706ISENTRESSISENTRESSDirect_RxNDACurrent
66336-214ISENTRESSRALTEGRAVIRDispensing Solutions, Inc.NDACurrent
67296-1235ISENTRESSISENTRESSRedPharm Drug, Inc.NDACurrent
67296-1235ISENTRESSISENTRESSRedPharm Drug, Inc.NDACurrent
67296-1235ISENTRESSISENTRESSRedPharm Drug, Inc.NDACurrent
68071-2113ISENTRESSRALTEGRAVIRNuCare Pharmaceuticals,Inc.NDACurrent
68071-2113ISENTRESSRALTEGRAVIRNuCare Pharmaceuticals,Inc.NDACurrent
68071-2113ISENTRESSRALTEGRAVIRNuCare Pharmaceuticals,Inc.NDACurrent
68071-2113ISENTRESSRALTEGRAVIRNuCare Pharmaceuticals,Inc.NDACurrent
70518-1621ISENTRESSRALTEGRAVIRREMEDYREPACK INC.NDACurrent
70518-1621ISENTRESSRALTEGRAVIRREMEDYREPACK INC.NDACurrent
70518-1621ISENTRESSRALTEGRAVIRREMEDYREPACK INC.NDACurrent
70518-1621ISENTRESSRALTEGRAVIRREMEDYREPACK INC.NDACurrent
76519-1130ISENTRESSRALTEGRAVIRH.J. Harkins Company Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67557SUPPL2021-05-20
67553SUPPL2021-05-19
63957SUPPL2020-07-17
63940SUPPL2020-07-16
54629SUPPL2018-06-20
53012SUPPL2018-03-15
52826SUPPL2018-03-06
50505SUPPL2017-12-06
50474SUPPL2017-11-24
48599SUPPL2017-05-31
48579SUPPL2017-05-31
6964SUPPL2015-02-24
38308SUPPL2015-02-23
17014SUPPL2015-02-20
6963SUPPL2015-02-19
29320SUPPL2014-04-10
17013SUPPL2014-04-10
29319SUPPL2013-12-31
38307SUPPL2013-12-23
6962SUPPL2013-10-25
29318SUPPL2013-08-06
17012SUPPL2013-08-05
17011SUPPL2013-07-03
6961SUPPL2013-07-02
38306SUPPL2013-04-09
29317SUPPL2013-04-09
38305SUPPL2012-08-15
29316SUPPL2012-08-15
6960SUPPL2012-04-23
17010SUPPL2012-04-20
42429SUPPL2012-04-13
29315SUPPL2012-04-02
38303SUPPL2012-03-28
6959SUPPL2011-12-28
38304SUPPL2011-12-23
17009SUPPL2011-11-16
6958SUPPL2011-11-07
6955SUPPL2011-06-17
6957SUPPL2011-04-13
38302SUPPL2011-04-11
38301SUPPL2011-03-04
6956SUPPL2011-03-01
38300SUPPL2010-07-06
17006SUPPL2010-07-06
29313SUPPL2010-07-02
6953SUPPL2010-07-02
17008SUPPL2010-04-04
6954SUPPL2010-04-02
29314SUPPL2010-01-20
17007SUPPL2009-11-23
6951SUPPL2009-07-15
38299SUPPL2009-07-09
29310SUPPL2009-02-09
17004SUPPL2009-02-04
29311SUPPL2009-02-03
17005SUPPL2009-01-14
6952SUPPL2009-01-14
38298SUPPL2008-11-07
29312SUPPL2008-10-28
42428ORIG2008-02-22
24250ORIG2008-02-22
29309ORIG2007-10-22
17003ORIG2007-10-15
64064ORIG1900-01-01
64063ORIG1900-01-01
64062ORIG1900-01-01
64061ORIG1900-01-01
64060ORIG1900-01-01
63547SUPPL1900-01-01
63546SUPPL1900-01-01
52953SUPPL1900-01-01
51636SUPPL1900-01-01
51635SUPPL1900-01-01
51634SUPPL1900-01-01