MERCK SHARP DOHME FDA Approval NDA 021029

NDA 021029

MERCK SHARP DOHME

FDA Drug Application

Application #021029

Documents

Letter2004-06-30
Letter2005-03-18
Letter2005-04-28
Letter2006-04-07
Letter2006-10-23
Letter2011-06-09
Letter2015-09-22
Label2002-01-18
Label2005-03-15
Label2011-02-09
Label2011-06-07
Label2015-09-23
Label2016-02-18
Letter1999-08-11
Letter2002-01-18
Letter2003-03-26
Letter2004-07-21
Letter2005-03-31
Letter2010-04-29
Letter2014-05-06
Letter2015-04-03
Letter2016-02-16
Label1999-08-11
Label2003-03-26
Label2006-10-23
Label2010-04-28
Label2013-01-09
Label2014-05-06
Label2015-04-07
Review1999-08-11
Review2004-04-14
Label2017-02-27
Letter2017-03-02
Label2017-10-10
Letter2017-10-12
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Written Request1900-01-01
Pediatric Amendment 11900-01-01
Label2019-11-25
Letter2019-11-26
Letter2020-11-25
Label2020-11-25

Application Sponsors

NDA 021029MERCK SHARP DOHME

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001CAPSULE;ORAL5MG1TEMODARTEMOZOLOMIDE
002CAPSULE;ORAL20MG1TEMODARTEMOZOLOMIDE
003CAPSULE;ORAL100MG1TEMODARTEMOZOLOMIDE
004CAPSULE;ORAL250MG1TEMODARTEMOZOLOMIDE
005CAPSULE;ORAL140MG1TEMODARTEMOZOLOMIDE
006CAPSULE;ORAL180MG1TEMODARTEMOZOLOMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1999-08-11PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2001-05-18PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-03-05PRIORITY
LABELING; LabelingSUPPL4AP2002-01-18STANDARD
EFFICACY; EfficacySUPPL5AP2003-03-11PRIORITY
LABELING; LabelingSUPPL6AP2004-07-15STANDARD
LABELING; LabelingSUPPL7AP2004-06-29STANDARD
EFFICACY; EfficacySUPPL8AP2005-03-15PRIORITY
LABELING; LabelingSUPPL9AP2005-03-30STANDARD
LABELING; LabelingSUPPL10AP2005-04-22STANDARD
LABELING; LabelingSUPPL11AP2006-03-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2006-10-19N/A
LABELING; LabelingSUPPL18AP2010-04-26STANDARD
LABELING; LabelingSUPPL20AP2011-02-04UNKNOWN
LABELING; LabelingSUPPL21AP2011-06-03UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2013-01-08PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2014-03-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2013-10-10PRIORITY
LABELING; LabelingSUPPL26AP2014-05-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2014-09-19PRIORITY
LABELING; LabelingSUPPL28AP2015-04-02STANDARD
LABELING; LabelingSUPPL29AP2015-09-18STANDARD
LABELING; LabelingSUPPL30AP2017-02-24STANDARD
LABELING; LabelingSUPPL31AP2016-02-12STANDARD
LABELING; LabelingSUPPL32AP2017-10-06STANDARD
LABELING; LabelingSUPPL33AP2019-11-22STANDARD
LABELING; LabelingSUPPL35AP2020-11-20STANDARD

Submissions Property Types

ORIG1Orphan5
SUPPL2Null14
SUPPL3Null14
SUPPL5Null8
SUPPL8Null41
SUPPL18Null6
SUPPL20Null7
SUPPL21Null6
SUPPL22Null14
SUPPL24Null14
SUPPL25Null14
SUPPL26Null7
SUPPL27Null14
SUPPL28Null6
SUPPL29Null6
SUPPL30Null7
SUPPL31Null7
SUPPL32Null15
SUPPL33Null15
SUPPL35Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

MERCK SHARP DOHME
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21029
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMODAR","activeIngredients":"TEMOZOLOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TEMODAR","activeIngredients":"TEMOZOLOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TEMODAR","activeIngredients":"TEMOZOLOMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TEMODAR","activeIngredients":"TEMOZOLOMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TEMODAR","activeIngredients":"TEMOZOLOMIDE","strength":"140MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TEMODAR","activeIngredients":"TEMOZOLOMIDE","strength":"180MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/22\/2019","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021029s033lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2017","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021029s032lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2017","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021029s030lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2016","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021029s031lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021029s029lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2015","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021029s028lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2015","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021029s028lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2014","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021029s026lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2013","submission":"SUPPL-22","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021029s022lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/03\/2011","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021029s021,022277s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2011","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021029s020,022277s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2010","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021029s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2006","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021029s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2006","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021029s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2005","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021029s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2003","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21029se8-005_temodar_lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2002","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/021029-S004_TEMODAR_lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/21029lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TEMODAR","submission":"TEMOZOLOMIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TEMODAR","submission":"TEMOZOLOMIDE","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TEMODAR","submission":"TEMOZOLOMIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TEMODAR","submission":"TEMOZOLOMIDE","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TEMODAR","submission":"TEMOZOLOMIDE","actionType":"140MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TEMODAR","submission":"TEMOZOLOMIDE","actionType":"180MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-11-22
        )

)
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