FDA.reportPublic FDA data

Application 021029

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMODARTEMOZOLOMIDECAPSULE;ORAL5MGYesNo
002TEMODARTEMOZOLOMIDECAPSULE;ORAL20MGYesNo
003TEMODARTEMOZOLOMIDECAPSULE;ORAL100MGYesNo
004TEMODARTEMOZOLOMIDECAPSULE;ORAL250MGYesYes
005TEMODARTEMOZOLOMIDECAPSULE;ORAL140MGYesNo
006TEMODARTEMOZOLOMIDECAPSULE;ORAL180MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1366TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1366TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1366TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1366TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1366TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1366TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1417TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1417TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1417TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1417TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1417TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1417TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1425TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1425TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1425TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1425TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1425TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1425TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1430TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1430TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1430TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1430TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1430TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1430TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1519TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1519TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1519TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1519TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-1519TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-1519TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-3004TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-3004TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-3004TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-3004TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0085-3004TEMODARTemozolomideMerck Sharp & Dohme Corp.NDACurrent
0085-3004TEMODARTemozolomideMerck Sharp & Dohme LLCNDACurrent
0781-2691TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2691TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2691TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2691TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2692TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2692TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2692TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2692TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2693TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2693TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2693TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2693TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2694TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2694TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2694TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2694TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2695TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2695TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2695TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2695TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2696TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2696TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2696TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent
0781-2696TemozolomideTemozolomideSandoz Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75594SUPPL 2023-09-28
75593SUPPL 2023-09-28
75592SUPPL 2023-09-28
75482SUPPL 2023-09-15
75481SUPPL 2023-09-15
75480SUPPL 2023-09-15
75459SUPPL 2023-09-14
75458SUPPL 2023-09-14
75457SUPPL 2023-09-14
65319SUPPL2020-11-25
65305SUPPL2020-11-25
61050SUPPL2019-11-26
61046SUPPL2019-11-25
50027SUPPL2017-10-12
49995SUPPL2017-10-10
47430SUPPL2017-03-02
47337SUPPL2017-02-27
14203SUPPL2016-02-18
26535SUPPL2016-02-16
14202SUPPL2015-09-23
4098SUPPL2015-09-22
35936SUPPL2015-04-07
26534SUPPL2015-04-03
35935SUPPL2014-05-06
26533SUPPL2014-05-06
35934SUPPL2013-01-09
4097SUPPL2011-06-09
14201SUPPL2011-06-07
14200SUPPL2011-02-09
26532SUPPL2010-04-29
35933SUPPL2010-04-28
35932SUPPL2006-10-23
4096SUPPL2006-10-23
4095SUPPL2006-04-07
4094SUPPL2005-04-28
26531SUPPL2005-03-31
4093SUPPL2005-03-18
14199SUPPL2005-03-15
26530SUPPL2004-07-21
4092SUPPL2004-06-30
41890SUPPL2004-04-14
35931SUPPL2003-03-26
26529SUPPL2003-03-26
26528SUPPL2002-01-18
14198SUPPL2002-01-18
41889ORIG1999-08-11
35930ORIG1999-08-11
26527ORIG1999-08-11
52217SUPPL1900-01-01
52216SUPPL1900-01-01
52215SUPPL1900-01-01
52214SUPPL1900-01-01
52213SUPPL1900-01-01