Documents
Application Sponsors
NDA 216157 | GLOBAL BLOOD THERAPS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET; ORAL SUSPENSION | 300MG | 0 | OXBRYTA | VOXELOTOR |
002 | TABLET;ORAL | 500MG | 0 | OXBRYTA | VOXELOTOR |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2021-12-17 | PRIORITY |
Submissions Property Types
CDER Filings
GLOBAL BLOOD THERAPS
cder:Array
(
[0] => Array
(
[ApplNo] => 216157
[companyName] => GLOBAL BLOOD THERAPS
[docInserts] => ["",""]
[products] => [{"drugName":"OXBRYTA","activeIngredients":"VOXELOTOR","strength":"300MG","dosageForm":"TABLET; ORAL SUSPENSION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"OXBRYTA","activeIngredients":"VOXELOTOR","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/216157s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/216157s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/216157Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-12-17
)
)