Documents
Application Sponsors
| BLA 125476 | TAKEDA PHARMS USA | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 300MG | 0 | ENTYVIO | VEDOLIZUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-05-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 2018-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2019-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2020-03-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2019-05-06 | N/A |
| LABELING; Labeling | SUPPL | 30 | AP | 2020-03-31 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2021-08-17 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2021-08-17 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | TA | 2022-04-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 48 | AP | 2023-01-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 30 | Null | 6 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 46 | Null | 46 |
| SUPPL | 48 | Null | 15 |
CDER Filings
TAKEDA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 125476
[companyName] => TAKEDA PHARMS USA
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/125476s038s039lbl.pdf#page=20"]
[products] => [{"drugName":"ENTYVIO","activeIngredients":"VEDOLIZUMAB","strength":"300MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
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[originalApprovals] => [{"actionDate":"05\/20\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125476s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125476Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125476Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125476Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/17\/2021","submission":"SUPPL-39","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/125476s038s039lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"08\/17\/2021","submission":"SUPPL-38","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/31\/2020","submission":"SUPPL-30","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125476s025s030lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"05\/06\/2019","submission":"SUPPL-27","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125476Orig1s027ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/31\/2020","submission":"SUPPL-25","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125476s025s030lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"05\/07\/2019","submission":"SUPPL-24","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125476s024lbl.pdf\"}]","notes":">"},{"actionDate":"02\/16\/2018","submission":"SUPPL-22","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125476s022lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125476Orig1s022ltr.pdf\"}]","notes":">"}]
[actionDate] => 2021-08-17
)
)