FDA.reportPublic FDA data

Application 021445

Type
NDA
Sponsor
MSD INTL GMBH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZETIAEZETIMIBETABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-778ZetiaEzetimibeRebel Distributors CorpNDACurrent
50090-0833ZetiaEzetimibeA-S Medication SolutionsNDACurrent
55154-5031ZetiaEzetimibeCardinal HealthNDACurrent
55154-5034ZetiaEzetimibeCardinal HealthNDACurrent
55154-5043ZetiaEzetimibeCardinal HealthNDACurrent
66582-414ZetiaEzetimibeMerck Sharp & Dohme Corp.NDACurrent
66582-414ZetiaEzetimibeMerck Sharp & Dohme Corp.NDACurrent
66582-414ZetiaEzetimibeMerck Sharp & Dohme Corp.NDACurrent
66582-414ZetiaEzetimibeMerck Sharp & Dohme Corp.NDACurrent
78206-178ZetiaEzetimibeOrganon LLCNDACurrent
78206-178ZetiaEzetimibeOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77598SUPPL 2024-02-22
77592SUPPL 2024-02-22
76738SUPPL 2023-12-05
74850SUPPL 2023-07-21
74842SUPPL 2023-07-21
68319SUPPL2021-08-09
68318SUPPL2021-08-09
36956SUPPL2014-10-30
27816SUPPL2014-10-14
27815SUPPL2012-01-30
15498SUPPL2012-01-25
15497SUPPL2011-08-12
5410SUPPL2011-08-12
27814SUPPL2009-11-25
5409SUPPL2009-11-25
15496SUPPL2009-07-23
15495SUPPL2009-07-23
36955SUPPL2009-02-04
5408SUPPL2009-02-04
36954SUPPL2008-06-12
15494SUPPL2008-06-12
27813SUPPL2008-06-09
5407SUPPL2008-06-09
42173SUPPL2008-02-19
21664SUPPL2008-02-19
21663SUPPL2008-02-19
15493SUPPL2008-02-14
5406SUPPL2008-02-13
44124ORIG2008-01-25
27812SUPPL2008-01-09
15492SUPPL2007-12-14
15491SUPPL2006-11-06
5405SUPPL2006-11-06
5402SUPPL2006-05-25
36951SUPPL2006-05-24
5404SUPPL2006-03-23
5401SUPPL2006-03-23
36953SUPPL2006-03-22
15490SUPPL2006-03-22
5403SUPPL2006-01-30
36952SUPPL2006-01-27
15489SUPPL2005-03-29
5400SUPPL2005-03-29
36950SUPPL2005-03-10
27811SUPPL2005-03-10
51734SUPPL2004-11-23
27810SUPPL2004-09-27
36949SUPPL2004-07-28
36948SUPPL2004-07-28
27809SUPPL2004-07-28
27808SUPPL2004-07-28
15488SUPPL2004-07-28
5399SUPPL2004-07-28
21662ORIG2003-02-03
27807ORIG2002-10-25
15487ORIG2002-10-25
63917ORIG1900-01-01
53278ORIG1900-01-01
53277ORIG1900-01-01
53276ORIG1900-01-01