Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET, DELAYED RELEASE;ORAL | 20MG | 1 | OMEPRAZOLE | OMEPRAZOLE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2007-12-04 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2009-04-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2009-09-21 | N/A |
LABELING; Labeling | SUPPL | 8 | AP | 2010-07-16 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2011-06-27 | UNKNOWN |
LABELING; Labeling | SUPPL | 16 | AP | 2012-04-09 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2012-09-10 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2012-10-29 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 2013-08-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2013-09-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2015-03-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2016-01-05 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2015-08-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2015-03-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2015-06-01 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2015-06-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2016-02-08 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2016-02-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2016-12-01 | STANDARD |
LABELING; Labeling | SUPPL | 37 | AP | 2017-10-30 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 2017-11-13 | STANDARD |
LABELING; Labeling | SUPPL | 41 | AP | 2019-04-08 | STANDARD |
LABELING; Labeling | SUPPL | 46 | AP | 2021-07-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2021-10-21 | N/A |
LABELING; Labeling | SUPPL | 57 | AP | 2022-09-30 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 31 |
SUPPL | 8 | Null | 7 |
SUPPL | 12 | Null | 6 |
SUPPL | 16 | Null | 6 |
SUPPL | 19 | Null | 15 |
SUPPL | 20 | Null | 15 |
SUPPL | 21 | Null | 6 |
SUPPL | 22 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 29 | Null | 15 |
SUPPL | 31 | Null | 0 |
SUPPL | 32 | Null | 15 |
SUPPL | 37 | Null | 15 |
SUPPL | 38 | Null | 6 |
SUPPL | 41 | Null | 7 |
SUPPL | 46 | Null | 7 |
SUPPL | 57 | Null | 7 |
CDER Filings
DEXCEL PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 22032
[companyName] => DEXCEL PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/08\/2019","submission":"SUPPL-41","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022032Orig1s041lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022032Orig1s038lbl.pdF\"}]","notes":""},{"actionDate":"10\/30\/2017","submission":"SUPPL-37","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022032Orig1s037lbl.pdf\"}]","notes":""},{"actionDate":"02\/10\/2016","submission":"SUPPL-32","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022032Orig1s032lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022032Orig1s029lbll.pdf\"}]","notes":""},{"actionDate":"03\/06\/2015","submission":"SUPPL-24","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022032Orig1s024lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/16\/2013","submission":"SUPPL-21","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022032Orig1s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2012","submission":"SUPPL-20","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022032Orig1s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2009","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022032s003lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"OMEPRAZOLE","submission":"OMEPRAZOLE","actionType":"20MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-04-08
)
)