NDA 022277

MERCK SHARP DOHME

FDA Drug Application

Application #022277

Documents

• Letter: 2009-03-05
• Letter: 2015-04-03
• Label: 2011-02-09
• Label: 2015-09-23
• Label: 2016-03-04
• Review: 2009-11-24
• Letter: 2010-04-29
• Letter: 2011-06-09
• Letter: 2014-05-06
• Letter: 2015-09-22
• Letter: 2016-02-16
• Label: 2009-04-03
• Label: 2010-04-28
• Label: 2011-06-07
• Label: 2014-05-06
• Label: 2015-04-07
• Summary Review: 2009-11-24
• Letter: 2017-03-02
• Label: 2017-03-31
• Label: 2017-10-10
• Letter: 2017-10-12
• Label: 2019-11-25
• Letter: 2019-11-26
• Letter: 2020-11-25
• Label: 2020-11-25

Application Sponsors

NDA 022277

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

100MG/VIAL

1

TEMODAR

TEMOZOLOMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2009-02-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2011-02-04	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2011-06-03	UNKNOWN
LABELING; Labeling	SUPPL	7	AP	2014-05-05	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-04-02	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-09-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-02-24	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-02-12	STANDARD
LABELING; Labeling	SUPPL	12	AP	2017-10-06	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-11-20	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	6
SUPPL	5	Null	6
SUPPL	7	Null	15
SUPPL	8	Null	6
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	6
SUPPL	13	Null	6
SUPPL	14	Null	7

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22277
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMODAR","activeIngredients":"TEMOZOLOMIDE","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/22\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022277s013lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2017","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022277s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022277s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022277s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022277s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022277s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022277s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2011","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021029s021,022277s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2011","submission":"SUPPL-4","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-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022277s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022277lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TEMODAR","submission":"TEMOZOLOMIDE","actionType":"100MG\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-11-22
        )

)