Documents
Application Sponsors
NDA 213137 | GLOBAL BLOOD THERAPS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 500MG | 1 | OXBRYTA | VOXELOTOR |
002 | TABLET;ORAL | 300MG | 1 | OXBRYTA | VOXELOTOR |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2019-11-25 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 6 | AP | 2021-12-17 | PRIORITY |
Submissions Property Types
CDER Filings
GLOBAL BLOOD THERAPS
cder:Array
(
[0] => Array
(
[ApplNo] => 213137
[companyName] => GLOBAL BLOOD THERAPS
[docInserts] => ["",""]
[products] => [{"drugName":"OXBRYTA","activeIngredients":"VOXELOTOR","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/17\/2021","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213137s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/213137s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/213137s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/213137Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/213137Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"12\/17\/2021","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213137s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213137Orig1s006ltr.pdf\"}]","notes":">"}]
[actionDate] => 2021-12-17
)
)