Documents
Application Sponsors
| NDA 205858 | GILEAD SCIENCES INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 100MG | 1 | ZYDELIG | IDELALISIB |
| 002 | TABLET;ORAL | 150MG | 1 | ZYDELIG | IDELALISIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-07-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2016-01-19 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-09-21 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 2017-01-04 | N/A |
| LABELING; Labeling | SUPPL | 7 | AP | 2017-11-29 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-01-26 | STANDARD |
| REMS; REMS | SUPPL | 10 | AP | 2018-02-06 | N/A |
| LABELING; Labeling | SUPPL | 11 | AP | 2018-02-02 | STANDARD |
| REMS; REMS | SUPPL | 12 | AP | 2018-03-22 | N/A |
| LABELING; Labeling | SUPPL | 13 | AP | 2018-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2020-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2022-02-18 | STANDARD |
| REMS; REMS | SUPPL | 17 | AP | 2022-03-10 | N/A |
| REMS; REMS | SUPPL | 18 | AP | 2022-07-06 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 30 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Orphan | 5 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 7 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205858
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/205858s011lbl.pdf#page=1"]
[products] => [{"drugName":"ZYDELIG","activeIngredients":"IDELALISIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZYDELIG","activeIngredients":"IDELALISIB","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/10\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205858s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205858s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2018","submission":"SUPPL-9","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205858s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205858s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205858s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/21\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205858s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/21\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205858s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205858lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/23\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205858lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205858Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205858Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205858Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/10\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205858s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205858Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"03\/22\/2018","submission":"SUPPL-12","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205858Orig1s012ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/02\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205858s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205858Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"02\/06\/2018","submission":"SUPPL-10","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205858Orig1s010ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/26\/2018","submission":"SUPPL-9","supplementCategories":"REMS - MODIFIED - D-N-A, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205858s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205858Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"11\/29\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205858s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205858Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"01\/04\/2017","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205858Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/21\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205858s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205858Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"01\/19\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/01\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-10-10
)
)