FDA.reportPublic FDA data

Application 022023

Type
NDA
Sponsor
MERCK AND CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMENDFOSAPREPITANT DIMEGLUMINEPOWDER;INTRAVENOUSEQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002EMENDFOSAPREPITANT DIMEGLUMINEPOWDER;INTRAVENOUSEQ 150MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3061EMENDFOSAPREPITANT DIMEGLUMINEMerck Sharp & Dohme LLCNDACurrent
0006-3061EMENDFOSAPREPITANT DIMEGLUMINEMerck Sharp & Dohme LLCNDACurrent
0006-3061EMENDfosaprepitant dimeglumineMerck Sharp & Dohme Corp.NDACurrent
0006-3061EMENDFOSAPREPITANT DIMEGLUMINEMerck Sharp & Dohme Corp.NDACurrent
0006-3061EMENDFOSAPREPITANT DIMEGLUMINEMerck Sharp & Dohme Corp.NDACurrent
0006-3061EMENDFOSAPREPITANT DIMEGLUMINEMerck Sharp & Dohme Corp.NDACurrent
0006-3061EMENDfosaprepitant dimeglumineMerck Sharp & Dohme Corp.NDACurrent
0006-3061EMENDfosaprepitant dimeglumineMerck Sharp & Dohme Corp.NDACurrent
0006-3061EMENDFOSAPREPITANT DIMEGLUMINEMerck Sharp & Dohme Corp.NDACurrent
0006-3061EMENDFOSAPREPITANT DIMEGLUMINEMerck Sharp & Dohme Corp.NDACurrent
0006-3061EMENDFOSAPREPITANT DIMEGLUMINEMerck Sharp & Dohme Corp.NDACurrent
0006-3061EMENDfosaprepitant dimeglumineMerck Sharp & Dohme Corp.NDACurrent
0006-3941EMENDFOSAPREPITANT DIMEGLUMINEMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70978SUPPL2022-05-04
70939SUPPL2022-05-03
65820SUPPL2021-01-06
60852SUPPL2019-11-15
60843SUPPL2019-11-15
57223SUPPL2019-01-15
53610SUPPL2018-04-05
53609SUPPL2018-04-05
53509SUPPL2018-03-29
53456SUPPL2018-03-27
52644SUPPL2018-02-14
49423SUPPL2017-08-15
49361SUPPL2017-08-15
48636SUPPL2017-06-02
48618SUPPL2017-06-01
47207SUPPL2017-02-15
38098SUPPL2017-02-07
6705SUPPL2016-02-03
6708SUPPL2014-08-14
16787SUPPL2014-08-13
42389SUPPL2014-01-17
38099SUPPL2013-04-01
6707SUPPL2013-03-29
16785SUPPL2013-03-26
29096SUPPL2013-03-22
6706SUPPL2012-07-11
16786SUPPL2012-07-10
29094SUPPL2010-11-18
38096SUPPL2010-11-17
38097SUPPL2010-03-26
38095SUPPL2010-03-26
16784SUPPL2010-03-26
29095SUPPL2010-03-25
29093SUPPL2010-03-25
6704SUPPL2010-03-25
21910ORIG2009-04-22
16783ORIG2008-01-30
6703ORIG2008-01-29
63924ORIG1900-01-01
63923ORIG1900-01-01
63922ORIG1900-01-01
63921ORIG1900-01-01
63012SUPPL1900-01-01
63011SUPPL1900-01-01