Documents
Application Sponsors
| NDA 022287 | TAKEDA PHARMS USA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE, DELAYED RELEASE;ORAL | 30MG | 1 | DEXILANT | DEXLANSOPRAZOLE |
| 002 | CAPSULE, DELAYED RELEASE;ORAL | 60MG | 1 | DEXILANT | DEXLANSOPRAZOLE |
FDA Submissions
| TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 2009-01-30 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2010-06-22 | UNKNOWN |
| LABELING; Labeling | SUPPL | 3 | AP | 2010-03-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 2010-03-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 5 | AP | 2010-09-03 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 7 | AP | 2011-04-07 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2011-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2011-10-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 12 | AP | 2011-05-20 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 14 | AP | 2012-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2012-05-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2012-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2013-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2015-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2014-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2016-02-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2016-07-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 22 | AP | 2016-07-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2016-07-08 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2016-10-24 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2016-10-24 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2017-10-17 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2018-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2018-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2020-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2020-11-27 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2022-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 34 | Null | 7 |
| SUPPL | 35 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
TAKEDA PHARMS USA
cder:Array
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[ApplNo] => 22287
[companyName] => TAKEDA PHARMS USA
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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022287s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2010","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022287s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2010","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022287s003lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DEXILANT","submission":"DEXLANSOPRAZOLE","actionType":"30MG","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DEXILANT","submission":"DEXLANSOPRAZOLE","actionType":"60MG","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-11-27
)
)