ASTRAZENECA FDA Approval NDA 210259

NDA 210259

ASTRAZENECA

FDA Drug Application

Application #210259

Documents

Label2017-10-31
Letter2017-10-31
Review2017-12-12
Label2019-11-21
Label2019-11-21
Letter2019-11-22
Letter2019-11-22
Review2020-02-03
Review2020-02-03
Letter2022-03-25
Label2022-03-25

Application Sponsors

NDA 210259ASTRAZENECA

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100MG1CALQUENCEACALABRUTINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2017-10-31PRIORITY
EFFICACY; EfficacySUPPL6AP2019-11-21PRIORITY
EFFICACY; EfficacySUPPL7AP2019-11-21PRIORITY
LABELING; LabelingSUPPL9AP2022-03-24STANDARD

Submissions Property Types

ORIG1Null1
SUPPL6Null7
SUPPL7Null7
SUPPL9Null15

CDER Filings

ASTRAZENECA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210259
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALQUENCE","activeIngredients":"ACALABRUTINIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/21\/2019","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210259s006s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210259s006s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/210259s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/210259s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/210259Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/210259Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/21\/2019","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210259s006s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"},{\"name\":\"Review (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/21\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210259s006s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"},{\"name\":\"Review (PDF)\",\"url\":\"\"}]","notes":">"}]
            [actionDate] => 2019-11-21
        )

)

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