Documents
Application Sponsors
| NDA 021856 | TAKEDA PHARMS USA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 40MG | 1 | ULORIC | FEBUXOSTAT |
| 002 | TABLET;ORAL | 80MG | 1 | ULORIC | FEBUXOSTAT |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2009-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2011-01-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 6 | AP | 2012-11-01 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2013-12-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2014-10-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2016-02-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2017-08-15 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2018-02-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2019-02-21 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 6 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
TAKEDA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 21856
[companyName] => TAKEDA PHARMS USA
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021856s013lbl.pdf#page=19"]
[products] => [{"drugName":"ULORIC","activeIngredients":"FEBUXOSTAT","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ULORIC","activeIngredients":"FEBUXOSTAT","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/21\/2019","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021856s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021856s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2017","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021856s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021856s006lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2011","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021856s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021856lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ULORIC","submission":"FEBUXOSTAT","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ULORIC","submission":"FEBUXOSTAT","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-02-21
)
)