Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 20MG | 1 | OMEPRAZOLE | OMEPRAZOLE |
FDA Submissions
TYPE 8; Type 8 - Partial Rx to OTC Switch | ORIG | 1 | AP | 2017-07-05 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2018-06-12 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2018-07-12 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2019-01-28 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2021-07-07 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-04-29 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2020-11-13 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2022-10-21 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 40 |
SUPPL | 2 | Null | 31 |
SUPPL | 3 | Null | 6 |
SUPPL | 5 | Null | 15 |
SUPPL | 6 | Null | 6 |
SUPPL | 7 | Null | 15 |
SUPPL | 10 | Null | 6 |
SUPPL | 12 | Null | 6 |
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
)
)