Documents
Application Sponsors
| NDA 208215 | GILEAD SCIENCES INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 200MG;EQ 25MG BASE | 1 | DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
| 002 | TABLET;ORAL | 120MG;EQ 15MG BASE | 1 | DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2016-04-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2017-09-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2019-12-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2019-10-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2020-11-24 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2021-09-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2022-01-07 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 6 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208215
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/208215s011lbl.pdf#page=37"]
[products] => [{"drugName":"DESCOVY","activeIngredients":"EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","strength":"200MG;EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/03\/2019","submission":"SUPPL-11","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208215s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2019","submission":"SUPPL-12","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208215s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2017","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208215s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208215s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208215s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/04\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208215s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208215Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208215Orig1_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208215Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/03\/2019","submission":"SUPPL-12","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208215s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208215Orig1s012ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/208215Orig1s012.pdf\"}]","notes":">"},{"actionDate":"12\/03\/2019","submission":"SUPPL-11","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208215s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208215Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"09\/28\/2017","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208215s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208215Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"04\/07\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208215s001lbl.pdf\"}]","notes":">"}]
[actionDate] => 2019-12-03
)
)