DEXCEL PHARMA FDA Approval NDA 209400

NDA 209400

DEXCEL PHARMA

FDA Drug Application

Application #209400

Documents

Letter2017-07-11
Label2017-07-11
Letter2018-03-01
Label2018-03-15
Review2018-03-21
Letter2018-06-14
Label2018-06-21
Letter2018-07-16
Label2018-08-03
Label2019-02-06
Letter2019-02-13
Letter2020-04-30
Label2020-04-30
Letter2020-11-17
Letter2021-07-08
Letter2022-10-24
Label2022-10-26

Application Sponsors

NDA 209400DEXCEL PHARMA

Marketing Status

Over-the-counter001

Application Products

001TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL20MG1OMEPRAZOLEOMEPRAZOLE

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC SwitchORIG1AP2017-07-05STANDARD
LABELING; LabelingSUPPL2AP2018-06-12STANDARD
LABELING; LabelingSUPPL3AP2018-07-12STANDARD
LABELING; LabelingSUPPL5AP2019-01-28STANDARD
LABELING; LabelingSUPPL6AP2021-07-07STANDARD
LABELING; LabelingSUPPL7AP2020-04-29STANDARD
LABELING; LabelingSUPPL10AP2020-11-13STANDARD
LABELING; LabelingSUPPL12AP2022-10-21STANDARD

Submissions Property Types

ORIG1Null40
SUPPL2Null31
SUPPL3Null6
SUPPL5Null15
SUPPL6Null6
SUPPL7Null15
SUPPL10Null6
SUPPL12Null6

CDER Filings

DEXCEL PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209400
            [companyName] => DEXCEL PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/29\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209400Orig1s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209400Orig1s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209400Orig1s003Lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209400Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209400Orig1s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/05\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209400Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/05\/2017","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\\\/2017\\\/209400Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209400Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209400Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/13\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209400Orig1s010ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/29\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209400Orig1s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209400Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"01\/28\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209400Orig1s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209400Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"07\/12\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209400Orig1s003Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209400Orig1s003Ltr.pdf\"}]","notes":">"},{"actionDate":"06\/12\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209400Orig1s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209400Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"02\/28\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209400Orig1s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209400Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-11-13
        )

)

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