Documents
Application Sponsors
NDA 214701 | BLUEPRINT MEDICINES | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 100MG | 2 | GAVRETO | PRALSETINIB |
FDA Submissions
TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval | ORIG | 1 | AP | 2020-12-01 | PRIORITY |
Submissions Property Types
CDER Filings
BLUEPRINT MEDICINES
cder:Array
(
[0] => Array
(
[ApplNo] => 214701
[companyName] => BLUEPRINT MEDICINES
[docInserts] => ["",""]
[products] => [{"drugName":"GAVRETO","activeIngredients":"PRALSETINIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"12\/01\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214701s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214701s000lbl.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-12-01
)
)