BELCHER FDA Approval NDA 202342

NDA 202342

BELCHER

FDA Drug Application

Application #202342

Documents

Letter2013-08-08
Letter2013-05-01
Label2013-08-09
Label2014-12-29
Letter2014-12-23
Review2013-11-13
Letter2016-10-26
Label2018-02-01
Label2018-06-12
Medication Guide2018-06-12
Letter2018-06-14
Label2020-11-30
Medication Guide2020-11-30
Letter2020-12-01
Letter2022-03-07
Label2022-03-11
Medication Guide2022-03-11

Application Sponsors

NDA 202342BELCHER

Marketing Status

Discontinued001
Discontinued002

Application Products

001CAPSULE, DELAYED RELEASE;ORAL24.65MG1ESOMEPRAZOLE STRONTIUMESOMEPRAZOLE STRONTIUM
002CAPSULE, DELAYED RELEASE;ORAL49.3MG1ESOMEPRAZOLE STRONTIUMESOMEPRAZOLE STRONTIUM

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP2013-08-06STANDARD
LABELING; LabelingSUPPL2AP2014-12-19901 REQUIRED
LABELING; LabelingSUPPL3AP2016-10-24STANDARD
LABELING; LabelingSUPPL5AP2018-06-07STANDARD
LABELING; LabelingSUPPL6AP2020-11-27STANDARD
LABELING; LabelingSUPPL7AP2022-03-04STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null6
SUPPL3Null6
SUPPL5Null15
SUPPL6Null6
SUPPL7Null6

CDER Filings

BELCHER
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202342
            [companyName] => BELCHER
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/202342s007lbl.pdf#page=29"]
            [products] => [{"drugName":"ESOMEPRAZOLE STRONTIUM","activeIngredients":"ESOMEPRAZOLE STRONTIUM","strength":"24.65MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ESOMEPRAZOLE STRONTIUM","activeIngredients":"ESOMEPRAZOLE STRONTIUM","strength":"49.3MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/04\/2022","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/202342s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202342s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202342s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202342s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202342s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202342s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/06\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202342s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/06\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202342s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202342Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202342Orig1s000TAltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/202342Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/04\/2022","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/202342s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/202342Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/27\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202342s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/202342Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"06\/07\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202342s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202342Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"10\/24\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202342s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202342Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"12\/19\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202342s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202342Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-03-04
        )

)
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