FDA.reportPublic FDA data

Application 021549

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMENDAPREPITANTCAPSULE;ORAL80MGYesNo
002EMENDAPREPITANTCAPSULE;ORAL125MGYesYes
003EMENDAPREPITANTCAPSULE;ORAL40MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0461EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0461EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0461EMENDaprepitantMerck Sharp & Dohme LLCNDACurrent
0006-0461EMENDaprepitantMerck Sharp & Dohme LLCNDACurrent
0006-0461EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0461EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0461EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0461EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0462EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0462EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0462EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0462EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0462EMENDaprepitantMerck Sharp & Dohme LLCNDACurrent
0006-0462EMENDaprepitantMerck Sharp & Dohme LLCNDACurrent
0006-0462EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0462EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0464EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0464EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0464EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0464EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0464EMENDaprepitantMerck Sharp & Dohme LLCNDACurrent
0006-0464EMENDaprepitantMerck Sharp & Dohme LLCNDACurrent
0006-0464EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-0464EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-3862EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-3862EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-3862EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-3862EMENDaprepitantMerck Sharp & Dohme LLCNDACurrent
0006-3862EMENDaprepitantMerck Sharp & Dohme LLCNDACurrent
0006-3862EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-3862EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
0006-3862EMENDaprepitantMerck Sharp & Dohme Corp.NDACurrent
42254-160EMENDaprepitantRebel Distributors CorpNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73958SUPPL 2023-04-06
60853SUPPL2019-11-15
60842SUPPL2019-11-15
60125SUPPL2019-09-26
60115SUPPL2019-09-26
48635SUPPL2017-06-02
48616SUPPL2017-06-01
15770SUPPL2015-09-03
5721SUPPL2015-09-01
28102SUPPL2014-08-14
15769SUPPL2014-08-13
15768SUPPL2013-04-01
5720SUPPL2013-03-29
37211SUPPL2013-03-26
5719SUPPL2013-03-22
28101SUPPL2012-07-11
37212SUPPL2012-07-10
21731SUPPL2012-03-02
15767SUPPL2010-03-26
5718SUPPL2010-03-25
37209SUPPL2009-07-23
28099SUPPL2009-07-23
15766SUPPL2009-02-04
5717SUPPL2009-02-04
28100SUPPL2008-11-21
37210SUPPL2008-11-19
28098SUPPL2007-11-19
21730SUPPL2007-11-19
15765SUPPL2007-11-19
28097SUPPL2006-07-13
15764SUPPL2006-07-03
37208SUPPL2006-06-14
5716SUPPL2006-06-12
37207SUPPL2005-11-01
5714SUPPL2005-11-01
15763SUPPL2005-06-14
5715SUPPL2005-06-14
37205SUPPL2004-12-30
5713SUPPL2004-12-30
37206SUPPL2004-12-29
28096SUPPL2004-12-29
5712SUPPL2004-01-22
42208ORIG2003-07-06
37204ORIG2003-03-28
28095ORIG2003-03-28
51589SUPPL1900-01-01
51587SUPPL1900-01-01
51585SUPPL1900-01-01
51583SUPPL1900-01-01
51581SUPPL1900-01-01
51530SUPPL1900-01-01