NDA 203045

MERCK SHARP DOHME

FDA Drug Application

Application #203045

Documents

• Letter: 2013-07-02
• Letter: 2013-04-09
• Letter: 2015-02-19
• Label: 2011-12-23
• Label: 2012-03-28
• Label: 2012-04-20
• Label: 2013-04-09
• Label: 2013-08-06
• Label: 2013-10-25
• Review: 2012-04-30
• Letter: 2011-12-27
• Letter: 2012-04-02
• Letter: 2012-04-23
• Letter: 2012-08-15
• Letter: 2013-08-06
• Letter: 2013-10-25
• Letter: 2013-12-31
• Letter: 2014-04-10
• Letter: 2015-02-24
• Label: 2012-08-15
• Label: 2013-07-03
• Label: 2013-12-23
• Label: 2014-04-10
• Label: 2015-02-20
• Label: 2015-02-23
• Summary Review: 2012-04-30
• Label: 2017-05-31
• Letter: 2017-05-31
• Label: 2017-11-24
• Letter: 2017-12-06
• Label: 2018-03-06
• Letter: 2018-03-12
• Label: 2020-07-16
• Letter: 2020-07-17
• Letter: 2021-05-19
• Label: 2021-05-20

Application Sponsors

NDA 203045

MERCK SHARP DOHME

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, CHEWABLE;ORAL	EQ 25MG BASE	1	ISENTRESS	RALTEGRAVIR POTASSIUM
002	TABLET, CHEWABLE;ORAL	EQ 100MG BASE	1	ISENTRESS	RALTEGRAVIR POTASSIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2011-12-21	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2012-04-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2012-08-10	901 REQUIRED
EFFICACY; Efficacy	SUPPL	4	AP	2013-06-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2013-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2013-05-28	PRIORITY
LABELING; Labeling	SUPPL	7	AP	2013-08-05	STANDARD
LABELING; Labeling	SUPPL	8	AP	2013-10-24	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2013-12-20	PRIORITY
LABELING; Labeling	SUPPL	10	AP	2014-04-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-02-18	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-02-20	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2017-05-26	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2017-11-22	PRIORITY
LABELING; Labeling	SUPPL	15	AP	2018-03-05	STANDARD
EFFICACY; Efficacy	SUPPL	16	AP	2020-07-14	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-05-18	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	0
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
SUPPL	15	Null	7
SUPPL	16	Null	15
SUPPL	17	Null	6

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203045
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
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            [actionDate] => 2020-07-14
        )

)