MERCK SHARP DOHME FDA Approval NDA 202258

Application #202258

Documents

Letter	2011-05-13
Letter	2012-08-01
Letter	2012-04-24
Letter	2013-02-15
Letter	2013-03-01
Letter	2013-02-20
Letter	2013-09-19
Letter	2014-04-10
Letter	2014-02-11
Letter	2014-02-26
Label	2012-12-28
Label	2013-02-20
Label	2014-04-10
Label	2014-01-22
Label	2014-02-25
Medication Guide	2011-05-17
Letter	2012-11-06
Letter	2012-12-26
Letter	2014-01-21
Letter	2014-07-29
Label	2011-05-13
Label	2012-07-30
Label	2012-04-24
Label	2013-02-14
Label	2013-03-01
Label	2012-11-28
Label	2013-09-19
Label	2014-02-10
Label	2014-07-29
Review	2011-06-15
FDA Press Release	2011-05-13
Other Important Information from FDA	2012-02-13
Summary Review	2011-06-15
Label	2017-01-30
Letter	2017-01-31

Application Sponsors

NDA 202258

MERCK SHARP DOHME

Marketing Status

Discontinued

001

Application Products

001

CAPSULE;ORAL

200MG

VICTRELIS

BOCEPREVIR

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2011-05-13	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2012-04-20	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2013-02-13	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2013-02-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2012-11-02	STANDARD
LABELING; Labeling	SUPPL	6	AP	2012-12-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2013-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2013-07-22	PRIORITY
LABELING; Labeling	SUPPL	9	AP	2013-09-18	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2014-04-09	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-01-17	STANDARD
LABELING; Labeling	SUPPL	13	AP	2014-02-07	STANDARD
LABELING; Labeling	SUPPL	14	AP	2014-02-24	STANDARD
LABELING; Labeling	SUPPL	15	AP	2014-07-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-01-30	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	15
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	5	Null	6
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	0
SUPPL	9	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	6
SUPPL	13	Null	6
SUPPL	14	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	6

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202258
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM255471.pdf"]
            [products] => [{"drugName":"VICTRELIS","activeIngredients":"BOCEPREVIR","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/30\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202258s016lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202258s016lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202258s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label 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Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202258s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202258s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202258s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202258s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202258lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/13\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202258lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202258Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202258Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202258Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/30\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202258s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202258Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"07\/28\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202258s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202258Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"02\/24\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202258s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202258Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"02\/07\/2014","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202258s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202258Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"01\/17\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202258s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202258Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"11\/02\/2012","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202258s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202258Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"02\/27\/2013","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202258s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202258Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"02\/13\/2013","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202258s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202258Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"04\/20\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202258s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202258s002ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202258s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202258Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2017-01-30
        )

)

NDA 202258

MERCK SHARP DOHME

FDA Drug Application

Application #202258

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

MERCK SHARP DOHME