NDA 213312

AADI BIOSCIENCE INC

FDA Drug Application

Application #213312

Documents

• Label: 2021-11-23
• Letter: 2021-11-24
• Review: 2022-08-30

Application Sponsors

NDA 213312

AADI BIOSCIENCE INC

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

100MG/VIAL

2

FYARRO

SIROLIMUS ALBUMIN-BOUND NANOPARTICLES

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-11-22

PRIORITY

Submissions Property Types

ORIG

1

Null

40

TE Codes

001

Prescription

TBD

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
        )

)