MAIA PHARMS INC FDA Approval NDA 215331

NDA 215331

MAIA PHARMS INC

FDA Drug Application

Application #215331

Documents

Letter2022-07-28
Label2022-07-28

Application Sponsors

NDA 215331MAIA PHARMS INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INTRAVENOUS, SUBCUTANEOUS3.5MG/3.5ML/VIAL0BORTEZOMIBBORTEZOMIB
002INJECTABLE;INTRAVENOUS, SUBCUTANEOUS3.5MG/1.4ML/VIAL0BORTEZOMIBBORTEZOMIB

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-07-27STANDARD

Submissions Property Types

ORIG1Null15

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
        )

)

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