AADI BIOSCIENCE INC FDA Approval NDA 213312

NDA 213312

AADI BIOSCIENCE INC

FDA Drug Application

Application #213312

Documents

Label2021-11-23
Letter2021-11-24

Application Sponsors

NDA 213312AADI BIOSCIENCE INC

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUS100MG/VIAL2FYARROSIROLIMUS ALBUMIN-BOUND NANOPARTICLES

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-11-22PRIORITY

Submissions Property Types

ORIG1Null40

TE Codes

001PrescriptionTBD

CDER Filings

AADI BIOSCIENCE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213312
            [companyName] => AADI BIOSCIENCE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FYARRO","activeIngredients":"SIROLIMUS ALBUMIN-BOUND NANOPARTICLES","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"11\/22\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213312lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213312lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213312Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-22
        )

)

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