FDA.reportPublic FDA data

Application 022277

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMODARTEMOZOLOMIDEPOWDER;INTRAVENOUS100MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1381TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1381TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1381TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1381TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1381TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1381TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75597SUPPL 2023-09-28
75596SUPPL 2023-09-28
75595SUPPL 2023-09-28
75485SUPPL 2023-09-15
75484SUPPL 2023-09-15
75483SUPPL 2023-09-15
75456SUPPL 2023-09-14
75455SUPPL 2023-09-14
75454SUPPL 2023-09-14
65318SUPPL2020-11-25
65306SUPPL2020-11-25
61051SUPPL2019-11-26
61045SUPPL2019-11-25
50026SUPPL2017-10-12
49994SUPPL2017-10-10
47801SUPPL2017-03-31
47433SUPPL2017-03-02
17190SUPPL2016-03-04
29516SUPPL2016-02-16
17189SUPPL2015-09-23
29515SUPPL2015-09-22
38491SUPPL2015-04-07
7161SUPPL2015-04-03
38490SUPPL2014-05-06
29514SUPPL2014-05-06
29513SUPPL2011-06-09
38489SUPPL2011-06-07
17188SUPPL2011-02-09
29512SUPPL2010-04-29
38488SUPPL2010-04-28
44725ORIG2009-11-24
21979ORIG2009-11-24
38487ORIG2009-04-03
7160ORIG2009-03-05