NDA 202343

MERCK SHARP DOHME

FDA Drug Application

Application #202343

Documents

• Letter: 2011-10-07
• Letter: 2012-09-24
• Letter: 2012-09-24
• Letter: 2013-02-13
• Label: 2012-09-20
• Label: 2012-09-20
• Label: 2012-11-06
• Label: 2013-10-31
• Label: 2013-08-19
• Label: 2014-02-25
• Medication Guide: 2011-10-07
• Letter: 2012-09-24
• Letter: 2012-11-06
• Letter: 2012-11-06
• Letter: 2013-10-28
• Letter: 2013-08-22
• Letter: 2014-02-26
• Label: 2011-10-07
• Label: 2012-09-20
• Label: 2012-11-06
• Label: 2013-02-11
• Review: 2012-07-13
• Summary Review: 2012-07-13

Application Sponsors

NDA 202343

MERCK SHARP DOHME

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

001	TABLET;ORAL	10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE
002	TABLET;ORAL	20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE
003	TABLET;ORAL	40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE
004	TABLET;ORAL	10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE
005	TABLET;ORAL	20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE
006	TABLET;ORAL	40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	JUVISYNC	SIMVASTATIN; SITAGLIPTIN PHOSPHATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2011-10-07	STANDARD
LABELING; Labeling	SUPPL	2	AP	2012-09-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	2012-09-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2012-10-31	STANDARD
LABELING; Labeling	SUPPL	6	AP	2013-02-11	STANDARD
LABELING; Labeling	SUPPL	7	AP	2012-10-31	STANDARD
LABELING; Labeling	SUPPL	8	AP	2013-10-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2013-11-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	2013-08-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-02-24	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202343
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM275945.pdf"]
            [products] => [{"drugName":"JUVISYNC","activeIngredients":"SIMVASTATIN; SITAGLIPTIN PHOSPHATE","strength":"10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"JUVISYNC","activeIngredients":"SIMVASTATIN; SITAGLIPTIN PHOSPHATE","strength":"20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"JUVISYNC","activeIngredients":"SIMVASTATIN; SITAGLIPTIN PHOSPHATE","strength":"40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"JUVISYNC","activeIngredients":"SIMVASTATIN; SITAGLIPTIN PHOSPHATE","strength":"10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"JUVISYNC","activeIngredients":"SIMVASTATIN; SITAGLIPTIN PHOSPHATE","strength":"20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"JUVISYNC","activeIngredients":"SIMVASTATIN; SITAGLIPTIN PHOSPHATE","strength":"40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/24\/2014","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202343s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2013","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202343s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2013","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202343s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2013","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202343s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2012","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202343s005s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2012","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202343s005s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2012","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202343s001s002s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2012","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202343s001s002s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2012","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202343s001s002s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202343s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/07\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202343s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202343s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202343Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202343Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/24\/2014","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202343s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202343Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"08\/19\/2013","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202343s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202343Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"11\/08\/2013","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/25\/2013","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202343s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202343Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"10\/31\/2012","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202343s005s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202343Orig1s005,s007ltr.pdf\"}]","notes":">"},{"actionDate":"02\/11\/2013","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202343s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202343Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"10\/31\/2012","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202343s005s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202343Orig1s005,s007ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2012","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202343s001s002s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202343Orig1S001,S002,S004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2012","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202343s001s002s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202343Orig1S001,S002,S004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2012","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202343s001s002s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202343Orig1S001,S002,S004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2014-02-24
        )

)