MSD INTL GMBH FDA Approval NDA 021445

NDA 021445

MSD INTL GMBH

FDA Drug Application

Application #021445

Documents

Letter2004-07-28
Letter2005-03-29
Letter2006-03-23
Letter2006-05-25
Letter2006-01-30
Letter2006-03-23
Letter2006-11-06
Letter2008-02-13
Letter2008-06-09
Letter2009-02-04
Letter2009-11-25
Letter2011-08-12
Label2002-10-25
Label2004-07-28
Label2005-03-29
Label2006-03-22
Label2006-11-06
Label2007-12-14
Label2008-02-14
Label2008-06-12
Label2009-07-23
Label2009-07-23
Label2011-08-12
Label2012-01-25
Review2003-02-03
Review2008-02-19
Review2008-02-19
Letter2002-10-25
Letter2004-07-28
Letter2004-07-28
Letter2004-09-27
Letter2005-03-10
Letter2008-01-09
Letter2008-06-09
Letter2009-11-25
Letter2012-01-30
Letter2014-10-14
Label2004-07-28
Label2004-07-28
Label2005-03-10
Label2006-05-24
Label2006-01-27
Label2006-03-22
Label2008-06-12
Label2009-02-04
Label2014-10-30
Review2008-02-19
Other Important Information from FDA2008-01-25
Pediatric Amendment 12004-11-23
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Written Request1900-01-01
Label2021-08-09
Letter2021-08-09

Application Sponsors

NDA 021445MSD INTL GMBH

Marketing Status

Prescription001

Application Products

001TABLET;ORAL10MG1ZETIAEZETIMIBE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2002-10-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2007-12-10STANDARD
LABELING; LabelingSUPPL3AP2004-07-23STANDARD
LABELING; LabelingSUPPL4AP2004-07-23STANDARD
LABELING; LabelingSUPPL6AP2004-09-22STANDARD
LABELING; LabelingSUPPL7AP2005-03-02STANDARD
LABELING; LabelingSUPPL11AP2005-03-22STANDARD
EFFICACY; EfficacySUPPL12AP2006-03-16UNKNOWN
EFFICACY; EfficacySUPPL13AP2006-05-23STANDARD
LABELING; LabelingSUPPL14AP2006-01-19STANDARD
LABELING; LabelingSUPPL15AP2006-03-16STANDARD
LABELING; LabelingSUPPL16AP2006-11-02STANDARD
LABELING; LabelingSUPPL18AP2007-12-10STANDARD
LABELING; LabelingSUPPL19AP2008-02-07STANDARD
EFFICACY; EfficacySUPPL20AP2008-06-05PRIORITY
LABELING; LabelingSUPPL21AP2008-06-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2009-01-27N/A
LABELING; LabelingSUPPL26AP2009-07-21STANDARD
LABELING; LabelingSUPPL27AP2009-07-21STANDARD
EFFICACY; EfficacySUPPL30AP2011-07-29STANDARD
EFFICACY; EfficacySUPPL33AP2012-01-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL34AP2013-01-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2013-02-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL36AP2013-06-04STANDARD
LABELING; LabelingSUPPL37AP2014-09-30UNKNOWN
LABELING; LabelingSUPPL40AP2019-10-03STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL20Null8
SUPPL30Null6
SUPPL33Null15
SUPPL34Null0
SUPPL35Null0
SUPPL36Null0
SUPPL37Null15
SUPPL40Null15

TE Codes

001PrescriptionAB

CDER Filings

MSD INTL GMBH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21445
            [companyName] => MSD INTL GMBH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZETIA","activeIngredients":"EZETIMIBE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/30\/2014","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021445Orig1s037lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2012","submission":"SUPPL-33","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021445s033lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2011","submission":"SUPPL-30","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021445s030lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2009","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021445s026s027lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2009","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021445s026s027lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2009","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021445s025lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2009","submission":"SUPPL-25","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021445s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2008","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021445s020s021lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2008","submission":"SUPPL-20","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021445s020s021lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2008","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021445s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2007","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021445s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2006","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021445s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2006","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021445s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2006","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021445s012,s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2006","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021445s012,s015lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2006","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021445s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2005","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/21445s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2005","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/21445s007lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2004","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21445s001,003,004lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2004","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21445s001,003,004lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2004","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21445s001,003,004lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21445lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZETIA","submission":"EZETIMIBE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-09-30
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.