DEXCEL PHARMA FDA Approval NDA 208025

NDA 208025

DEXCEL PHARMA

FDA Drug Application

Application #208025

Documents

Letter2016-06-13
Review2016-11-22
Letter2017-01-30
Label2017-01-30
Letter2017-05-12
Label2017-05-15
Letter2017-11-15
Letter2017-12-01
Label2017-12-04
Label2017-12-04
Letter2017-12-04
Letter2019-04-10
Label2019-04-29
Letter2020-11-25
Label2020-11-25
Letter2022-11-02
Label2022-11-07

Application Sponsors

NDA 208025DEXCEL PHARMA

Marketing Status

Over-the-counter001

Application Products

001TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL15MG0LANSOPRAZOLELANSOPRAZOLE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2016-06-07STANDARD
LABELING; LabelingSUPPL3AP2017-05-09STANDARD
LABELING; LabelingSUPPL5AP2017-11-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2017-11-30N/A
LABELING; LabelingSUPPL7AP2017-11-30STANDARD
LABELING; LabelingSUPPL8AP2019-04-09STANDARD
LABELING; LabelingSUPPL10AP2020-11-20STANDARD
LABELING; LabelingSUPPL12AP2022-11-01STANDARD

Submissions Property Types

ORIG1Null40
SUPPL3Null15
SUPPL5Null15
SUPPL6Null15
SUPPL7Null6
SUPPL8Null6
SUPPL10Null6
SUPPL12Null7

CDER Filings

DEXCEL PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208025
            [companyName] => DEXCEL PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/20\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208025Orig1s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/09\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208025Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208025Orig1s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208025s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208025Orig1s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208025Orig1s001lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208025Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208025Orig1s000TOC.cfm\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/20\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208025Orig1s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208025Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"04\/09\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208025Orig1s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208025Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"11\/30\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208025Orig1s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208025Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/30\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208025s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208025s006ltr.pdf\"}]","notes":">"},{"actionDate":"11\/15\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208025Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/09\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208025Orig1s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208025Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"01\/25\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208025Orig1s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208025Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-11-20
        )

)

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