Documents
Application Sponsors
NDA 215331 | MAIA PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 3.5MG/3.5ML/VIAL | 0 | BORTEZOMIB | BORTEZOMIB |
002 | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 3.5MG/1.4ML/VIAL | 0 | BORTEZOMIB | BORTEZOMIB |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2022-07-27 | STANDARD |
Submissions Property Types
CDER Filings
MAIA PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 215331
[companyName] => MAIA PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"3.5MG\/3.5ML\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"3.5MG\/1.4ML\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/27\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215331s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215331s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215331Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2022-07-27
)
)