Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 15MG | 0 | LANSOPRAZOLE | LANSOPRAZOLE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2016-06-07 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2017-05-09 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2017-11-15 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2017-11-30 | N/A |
LABELING; Labeling | SUPPL | 7 | AP | 2017-11-30 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2019-04-09 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2020-11-20 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2022-11-01 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 40 |
SUPPL | 3 | Null | 15 |
SUPPL | 5 | Null | 15 |
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 6 |
SUPPL | 8 | Null | 6 |
SUPPL | 10 | Null | 6 |
SUPPL | 12 | Null | 7 |
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
)
)