Documents
Application Sponsors
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 100MG | 1 | CALQUENCE | ACALABRUTINIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2017-10-31 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2019-11-21 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2019-11-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-03-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 1 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 9 | Null | 15 |
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
)
)