NDA 021995

MERCK SHARP DOHME

FDA Drug Application

Application #021995

Documents

• Letter: 2006-10-23
• Letter: 2007-10-22
• Letter: 2010-03-05
• Letter: 2010-01-14
• Letter: 2010-03-05
• Letter: 2011-04-19
• Letter: 2012-03-27
• Letter: 2013-02-08
• Letter: 2013-08-22
• Letter: 2015-04-29
• Label: 2010-03-02
• Label: 2010-03-02
• Label: 2010-09-29
• Label: 2011-04-18
• Label: 2012-02-27
• Label: 2012-03-27
• Label: 2012-10-22
• Review: 2015-03-11
• Letter: 2007-10-22
• Letter: 2007-10-22
• Letter: 2007-10-22
• Letter: 2008-07-23
• Letter: 2008-10-23
• Letter: 2010-03-05
• Letter: 2010-03-05
• Letter: 2010-09-29
• Letter: 2011-06-17
• Letter: 2010-09-29
• Letter: 2012-10-22
• Letter: 2015-03-12
• Letter: 2015-09-01
• Label: 2006-10-18
• Label: 2008-07-23
• Label: 2010-03-02
• Label: 2010-03-02
• Label: 2010-01-12
• Label: 2010-09-29
• Label: 2013-02-08
• Label: 2013-10-22
• Label: 2013-08-21
• Label: 2015-03-12
• Label: 2015-05-04
• Label: 2015-09-04
• Review: 2006-12-13
• Review: 2015-03-11
• Other Important Information from FDA: 2013-04-29
• Label: 2017-01-18
• Letter: 2017-01-24
• Label: 2017-08-14
• Letter: 2017-08-15
• Label: 2018-02-12
• Medication Guide: 2018-02-12
• Letter: 2018-02-14
• Letter: 2019-07-02
• Label: 2019-07-09
• Medication Guide: 2019-07-09
• Letter: 2019-08-13
• Label: 2019-08-13
• Medication Guide: 2019-08-13
• Label: 2020-12-04
• Letter: 2020-12-08
• Medication Guide: 2020-12-09
• Letter: 2022-06-22
• Label: 2022-06-24
• Medication Guide: 2022-06-24

Application Sponsors

NDA 021995

MERCK SHARP DOHME

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	EQ 25MG BASE	1	JANUVIA	SITAGLIPTIN PHOSPHATE
002	TABLET;ORAL	EQ 50MG BASE	1	JANUVIA	SITAGLIPTIN PHOSPHATE
003	TABLET;ORAL	EQ 100MG BASE	1	JANUVIA	SITAGLIPTIN PHOSPHATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2006-10-16	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2007-10-12	UNKNOWN
EFFICACY; Efficacy	SUPPL	3	AP	2007-10-12	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2007-10-12	STANDARD
LABELING; Labeling	SUPPL	6	AP	2007-10-12	STANDARD
LABELING; Labeling	SUPPL	7	AP	2008-07-22	STANDARD
LABELING; Labeling	SUPPL	9	AP	2008-10-20	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2010-02-26	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2010-02-26	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2010-02-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	2009-12-28	901 REQUIRED
LABELING; Labeling	SUPPL	14	AP	2010-02-26	901 REQUIRED
EFFICACY; Efficacy	SUPPL	15	AP	2010-09-24	STANDARD
LABELING; Labeling	SUPPL	16	AP	2011-06-10	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2011-04-14	UNKNOWN
LABELING; Labeling	SUPPL	18	AP	2010-09-24	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2012-02-27	N/A
LABELING; Labeling	SUPPL	23	AP	2012-03-24	UNKNOWN
LABELING; Labeling	SUPPL	25	AP	2012-10-18	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2012-12-07	STANDARD
LABELING; Labeling	SUPPL	27	AP	2013-02-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2013-10-17	STANDARD
LABELING; Labeling	SUPPL	29	AP	2013-08-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2015-03-10	STANDARD
LABELING; Labeling	SUPPL	33	AP	2015-04-27	STANDARD
LABELING; Labeling	SUPPL	34	AP	2015-08-28	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2016-01-11	STANDARD
LABELING; Labeling	SUPPL	38	AP	2017-01-18	STANDARD
LABELING; Labeling	SUPPL	40	AP	2017-08-10	STANDARD
LABELING; Labeling	SUPPL	42	AP	2018-02-09	STANDARD
EFFICACY; Efficacy	SUPPL	45	AP	2019-08-12	STANDARD
LABELING; Labeling	SUPPL	46	AP	2019-07-01	901 REQUIRED
EFFICACY; Efficacy	SUPPL	47	AP	2020-12-04	PRIORITY
LABELING; Labeling	SUPPL	50	AP	2022-06-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	10	Null	7
SUPPL	11	Null	6
SUPPL	12	Null	6
SUPPL	13	Null	6
SUPPL	14	Null	6
SUPPL	15	Null	6
SUPPL	16	Null	6
SUPPL	17	Null	6
SUPPL	18	Null	6
SUPPL	19	Null	6
SUPPL	23	Null	6
SUPPL	25	Null	6
SUPPL	26	Null	0
SUPPL	27	Null	15
SUPPL	28	Null	0
SUPPL	29	Null	6
SUPPL	32	Null	0
SUPPL	33	Null	6
SUPPL	34	Null	6
SUPPL	35	Null	0
SUPPL	38	Null	6
SUPPL	40	Null	15
SUPPL	42	Null	6
SUPPL	45	Null	7
SUPPL	46	Null	7
SUPPL	47	Null	15
SUPPL	50	Null	7

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21995
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021995s045lbl.pdf#page=27"]
            [products] => [{"drugName":"JANUVIA","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JANUVIA","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JANUVIA","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/12\/2019","submission":"SUPPL-45","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021995s045lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2019","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021995s046lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2018","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021995s042lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021995s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2011","submission":"SUPPL-17","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021995s017lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2010","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021995s015s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2010","submission":"SUPPL-15","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label 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            [originalApprovals] => [{"actionDate":"JANUVIA","submission":"SITAGLIPTIN PHOSPHATE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"JANUVIA","submission":"SITAGLIPTIN PHOSPHATE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"JANUVIA","submission":"SITAGLIPTIN PHOSPHATE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-08-12
        )

)