Documents
Application Sponsors
| NDA 205552 | PHARMACYCLICS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 140MG | 1 | IMBRUVICA | IBRUTINIB |
| 002 | CAPSULE;ORAL | 70MG | 1 | IMBRUVICA | IBRUTINIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2013-11-13 | PRIORITY |
| EFFICACY; Efficacy | ORIG | 2 | AP | 2014-02-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2015-08-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2015-08-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2015-08-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2016-03-21 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2016-03-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2016-02-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2015-11-25 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2016-05-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2016-04-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 12 | AP | 2016-06-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2016-05-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2016-06-27 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2017-01-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2017-08-02 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2017-12-20 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2018-08-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 2018-08-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2019-01-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 28 | AP | 2019-07-15 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2019-11-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 2020-04-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 31 | AP | 2020-08-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 32 | AP | 2020-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2020-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2022-05-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2022-08-24 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 37 | AP | 2022-08-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 38 | AP | 2022-08-24 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| ORIG | 2 | Null | 40 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 4 | Null | 14 |
| SUPPL | 5 | Null | 14 |
| SUPPL | 6 | Null | 14 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 14 |
| SUPPL | 9 | Null | 14 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 14 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 14 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Orphan | 5 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 30 | Orphan | 5 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 35 | Null | 7 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 38 | Orphan | 5 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
PHARMACYCLICS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205552
[companyName] => PHARMACYCLICS INC
[docInserts] => ["",""]
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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205552Orig1s024,210563Orig1s001ltr.pdf\"}]","notes":">"},{"actionDate":"12\/20\/2017","submission":"SUPPL-20","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205552s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205552Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"08\/02\/2017","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205552s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205552Orig1s017ltr.pdf\"},{\"name\":\"Review 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205552s010s013lbl.pdf\"}]","notes":">"},{"actionDate":"06\/28\/2016","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205552Orig1s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205552Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"04\/13\/2016","submission":"SUPPL-11","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/06\/2016","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205552s010s013lbl.pdf\"},{\"name\":\"Letter 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(CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/24\/2015","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/17\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/13\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/29\/2015","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205552s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205552Orig1s002ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2021\\\/205552Orig1s002.pdf\"}]","notes":">"},{"actionDate":"07\/28\/2014","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205552s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205552Orig1s001ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205552s001.pdf\"}]","notes":">"}]
[actionDate] => 2022-08-24
)
)