ASTRAZENECA UK LTD FDA Approval NDA 216387

NDA 216387

ASTRAZENECA UK LTD

FDA Drug Application

Application #216387

Documents

Letter2022-08-05
Label2022-08-05
Label2022-08-05

Application Sponsors

NDA 216387ASTRAZENECA UK LTD

Marketing Status

Prescription001

Application Products

001TABLET, FILM COATED100MG0CALQUENCEACALABRUTINIB

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-08-03STANDARD
TYPE 3; Type 3 - New Dosage FormORIG2AP2022-08-03STANDARD

Submissions Property Types

ORIG1Null15
ORIG2Null7

CDER Filings

ASTRAZENECA UK LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216387
            [companyName] => ASTRAZENECA UK LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALQUENCE","activeIngredients":"ACALABRUTINIB","strength":"100MG","dosageForm":"TABLET, FILM COATED","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/03\/2022","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216387Orig2s000Correctedlbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216387Orig1s000Correctedlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/03\/2022","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216387Orig2s000Correctedlbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216387Orig2s000Correctedltr.pdf\"}]","notes":">"},{"actionDate":"08\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216387Orig1s000Correctedlbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-08-03
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.