ASTRAZENECA LP FDA Approval NDA 204655

NDA 204655

ASTRAZENECA LP

FDA Drug Application

Application #204655

Documents

Letter2014-04-02
Letter2014-10-06
Label2015-06-03
Review2014-12-09
Summary Review2014-12-09
Label2014-03-31
Label2014-10-06
Letter2017-01-17
Label2017-01-24
Label2017-02-06
Letter2017-02-06
Letter2018-01-26
Label2018-02-06
Label2019-04-08
Letter2019-04-08
Letter2020-12-08
Letter2022-09-07
Label2022-09-09

Application Sponsors

NDA 204655ASTRAZENECA LP

Marketing Status

Over-the-counter001

Application Products

001CAPSULE, DELAYED RELEASE;ORALEQ 20MG BASE1NEXIUM 24HRESOMEPRAZOLE MAGNESIUM

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC SwitchORIG1AP2014-03-28STANDARD
LABELING; LabelingSUPPL2AP2015-06-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2015-06-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2016-06-17STANDARD
LABELING; LabelingSUPPL6AP2017-01-09STANDARD
LABELING; LabelingSUPPL7AP2017-02-03STANDARD
LABELING; LabelingSUPPL9AP2018-01-24STANDARD
LABELING; LabelingSUPPL11AP2019-04-04STANDARD
LABELING; LabelingSUPPL14AP2020-12-04STANDARD
LABELING; LabelingSUPPL18AP2022-09-06STANDARD

Submissions Property Types

ORIG1Null40
SUPPL2Null6
SUPPL3Null0
SUPPL4Null0
SUPPL6Null7
SUPPL7Null15
SUPPL9Null7
SUPPL11Null7
SUPPL14Null6
SUPPL18Null6

CDER Filings

ASTRAZENECA LP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204655
            [companyName] => ASTRAZENECA LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEXIUM 24HR","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/04\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204655Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204655Orig1s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204655Orig1s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204655Orig1s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204655Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204655Orig1s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204655Orig1s000Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/28\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 8 - Partial Rx to OTC Switch","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204655Orig1s000Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204655Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204655Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204655Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/04\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204655Orig1s014ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/04\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204655Orig1s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204655Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"01\/24\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204655Orig1s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204655Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"02\/03\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204655Orig1s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204655Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"01\/09\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204655Orig1s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204655Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"06\/17\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/23\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/02\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204655Orig1s002lbl.pdf\"}]","notes":">"},{"actionDate":"10\/03\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204655Orig1s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204655Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-12-04
        )

)
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