FDA.report

Application 021687

Type
NDA
Sponsor
MSD INTL

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001VYTORINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;10MGYesNo
002VYTORINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;20MGYesNo
003VYTORINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;40MGYesNo
004VYTORINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;80MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-325VYTORINezetimibe and simvastatinRebel Distributors CorpNDACurrent
21695-339VYTORINezetimibe and simvastatinRebel Distributors CorpNDACurrent
21695-827VYTORINezetimibe and simvastatinRebel Distributors CorpNDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-280VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-520VYTORINezetimibe and simvastatinPD-Rx Pharmaceuticals, Inc.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-311VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-312VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-313VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
66582-315VYTORINezetimibe and simvastatinMerck Sharp & Dohme Corp.NDACurrent
78206-174VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-174VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-175VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-175VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-176VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-176VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-177VYTORINezetimibe and simvastatinOrganon LLCNDACurrent
78206-177VYTORINezetimibe and simvastatinOrganon LLCNDACurrent

Documents

DocumentSubmission typeDate
78021SUPPL 2024-04-01
78010SUPPL 2024-04-01
77456SUPPL 2024-02-09
77455SUPPL 2024-02-09
77454SUPPL 2024-02-09
77453SUPPL 2024-02-09
77452SUPPL 2024-02-09
77451SUPPL 2024-02-09
77450SUPPL 2024-02-09
64730SUPPL2020-09-29
64703SUPPL2020-09-28
60571SUPPL2019-10-15
60439SUPPL2019-10-09
58208SUPPL2019-04-04
58193SUPPL2019-04-02
52777SUPPL2018-03-01
52776SUPPL2018-03-01
48430SUPPL2017-05-17
28372SUPPL2015-02-03
15982SUPPL2015-02-03
5979SUPPL2014-10-14
37451SUPPL2014-03-04
28371SUPPL2014-02-28
37450SUPPL2013-10-31
5978SUPPL2013-10-28
28370SUPPL2012-11-06
5977SUPPL2012-11-06
37449SUPPL2012-11-02
15981SUPPL2012-11-02
42270SUPPL2012-06-06
15980SUPPL2012-03-06
5976SUPPL2012-02-29
5975SUPPL2012-01-30
37448SUPPL2012-01-25
28369SUPPL2011-12-05
15979SUPPL2011-12-02
28368SUPPL2011-10-12
15978SUPPL2011-10-12
28367SUPPL2011-06-08
15977SUPPL2011-06-08
15974SUPPL2011-06-08
5973SUPPL2011-06-08
28366SUPPL2010-12-28
15976SUPPL2010-12-26
37447SUPPL2010-05-03
5974SUPPL2010-04-28
28365SUPPL2010-03-18
15975SUPPL2010-03-17
28364SUPPL2010-01-21
15973SUPPL2009-11-23
15972SUPPL2009-02-04
5972SUPPL2009-02-03
15971SUPPL2009-01-14
28363SUPPL2009-01-12
37446SUPPL2008-02-14
28362SUPPL2008-02-14
44142ORIG2008-01-25
28361SUPPL2008-01-09
15970SUPPL2007-12-14
15969SUPPL2007-05-29
5971SUPPL2007-05-29
28360SUPPL2006-12-04
15968SUPPL2006-12-04
5968SUPPL2006-10-26
37443SUPPL2006-10-25
28359SUPPL2006-10-05
15967SUPPL2006-10-05
5970SUPPL2006-07-13
37445SUPPL2006-07-05
28357SUPPL2006-03-23
5969SUPPL2006-03-23
37444SUPPL2006-03-22
15966SUPPL2006-03-22
37442SUPPL2005-12-15
28358SUPPL2005-12-15
15965SUPPL2005-10-24
37441SUPPL2005-06-07
5967SUPPL2005-06-07
37440SUPPL2005-03-10
28356SUPPL2005-03-10
28355SUPPL2005-02-17
21778ORIG2004-11-22
28354ORIG2004-07-28
15964ORIG2004-07-28
53275ORIG1900-01-01
53274ORIG1900-01-01
53273ORIG1900-01-01