JAZZ PHARMS FDA Approval NDA 021196

NDA 021196

JAZZ PHARMS

FDA Drug Application

Application #021196

Documents

Letter2002-07-17
Letter2015-03-02
Letter2015-07-16
Label2002-07-17
Label2005-11-22
Label2012-12-17
Label2016-02-24
Review2002-07-17
Letter2003-11-25
Letter2005-11-22
Letter2005-09-22
Letter2006-07-03
Letter2006-11-16
Letter2012-12-20
Letter2014-04-14
Label2014-04-14
Other Important Information from FDA2012-12-17
Other2015-07-07
Label2017-01-26
Letter2017-01-30
Label2017-07-13
Label2017-11-17
Letter2017-11-17
Review2018-05-08
Label2018-10-26
Medication Guide2018-10-26
Letter2018-10-29
Label2019-09-11
Letter2019-09-12
Review2019-09-20
Label2020-07-22
Label2020-07-22
Medication Guide2020-07-22
Medication Guide2020-07-22
Letter2020-07-22
Letter2020-07-22
Letter2020-09-29
Label2020-09-29
Medication Guide2020-09-29
Letter2021-02-16
Label2021-02-17
Letter2021-08-13
Letter2021-12-14
Letter2022-02-10
Letter2022-08-23
Label2022-08-25
Medication Guide2022-08-25
Review2022-10-12

Application Sponsors

NDA 021196JAZZ PHARMS

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL500MG/ML1XYREMSODIUM OXYBATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2002-07-17PRIORITY
EFFICACY; EfficacySUPPL5AP2005-11-18UNKNOWN
LABELING; LabelingSUPPL7AP2005-09-16STANDARD
LABELING; LabelingSUPPL9AP2006-06-30STANDARD
LABELING; LabelingSUPPL12AP2006-11-13STANDARD
LABELING; LabelingSUPPL13AP2012-12-17STANDARD
LABELING; LabelingSUPPL15AP2015-02-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2013-12-20PRIORITY
EFFICACY; EfficacySUPPL19AP2014-04-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2015-02-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2015-08-17PRIORITY
LABELING; LabelingSUPPL23AP2015-07-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2016-06-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2017-04-19N/A
LABELING; LabelingSUPPL27AP2017-01-26STANDARD
LABELING; LabelingSUPPL28AP2017-11-16STANDARD
EFFICACY; EfficacySUPPL30AP2018-10-26PRIORITY
LABELING; LabelingSUPPL31AP2019-05-09STANDARD
EFFICACY; EfficacySUPPL32AP2020-09-25STANDARD
LABELING; LabelingSUPPL33AP2020-07-21STANDARD
REMS; REMSSUPPL34AP2020-07-21N/A
REMS; REMSSUPPL35AP2021-02-11N/A
REMS; REMSSUPPL36AP2021-08-12N/A
REMS; REMSSUPPL38AP2021-12-09N/A
REMS; REMSSUPPL39AP2022-02-09N/A
LABELING; LabelingSUPPL40AP0000-00-00STANDARD

Submissions Property Types

ORIG1Orphan5
SUPPL13Null15
SUPPL15Null15
SUPPL18Null14
SUPPL19Null6
SUPPL20Null14
SUPPL22Null14
SUPPL23Null6
SUPPL25Null14
SUPPL26Orphan5
SUPPL27Null7
SUPPL28Null15
SUPPL30Null7
SUPPL32Null7
SUPPL33Null6
SUPPL34Null7
SUPPL35Null15
SUPPL36Null6
SUPPL38Orphan5
SUPPL39Null6
SUPPL40Null7

TE Codes

001PrescriptionAA

CDER Filings

JAZZ PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21196
            [companyName] => JAZZ PHARMS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/021196s032lbl.pdf#page=26"]
            [products] => [{"drugName":"XYREM","activeIngredients":"SODIUM OXYBATE","strength":"0.5GM\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/25\/2020","submission":"SUPPL-32","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021196s032lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2020","submission":"SUPPL-34","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021196s033s034lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2020","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021196s033s034lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2019","submission":"SUPPL-31","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021196Orig1s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-30","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021196s030lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021196s028lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2017","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021196s026lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2017","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021196s027lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2015","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/scripts\\\/cder\\\/rems\\\/index.cfm?event=IndvRemsDetails.page&REMS=345\"}]","notes":""},{"actionDate":"04\/11\/2014","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021196Orig1s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2012","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021196s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2005","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021196s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21196lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"XYREM","submission":"SODIUM OXYBATE","actionType":"0.5GM\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-09-25
        )

)
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