NDA 216157

GLOBAL BLOOD THERAPS

FDA Drug Application

Application #216157

Documents

• Label: 2021-12-19
• Letter: 2021-12-15
• Review: 2022-07-14

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

ORIG

1

Null

15

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
        )

)