Application 202343

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JUVISYNCSIMVASTATIN; SITAGLIPTIN PHOSPHATETABLET;ORAL10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002JUVISYNCSIMVASTATIN; SITAGLIPTIN PHOSPHATETABLET;ORAL20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003JUVISYNCSIMVASTATIN; SITAGLIPTIN PHOSPHATETABLET;ORAL40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004JUVISYNCSIMVASTATIN; SITAGLIPTIN PHOSPHATETABLET;ORAL10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005JUVISYNCSIMVASTATIN; SITAGLIPTIN PHOSPHATETABLET;ORAL20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
006JUVISYNCSIMVASTATIN; SITAGLIPTIN PHOSPHATETABLET;ORAL40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32243SUPPL2014-02-26
19330SUPPL2014-02-25
19328SUPPL2013-10-31
32241SUPPL2013-10-28
32242SUPPL2013-08-22
19329SUPPL2013-08-19
10033SUPPL2013-02-13
40172SUPPL2013-02-11
40171SUPPL2012-11-06
32240SUPPL2012-11-06
32239SUPPL2012-11-06
19327SUPPL2012-11-06
32238SUPPL2012-09-24
10032SUPPL2012-09-24
10031SUPPL2012-09-24
40170SUPPL2012-09-20
19326SUPPL2012-09-20
19325SUPPL2012-09-20
44853ORIG2012-07-13
43397ORIG2012-07-13
40169ORIG2011-10-07
23492ORIG2011-10-07
10030ORIG2011-10-07