Documents
Application Sponsors
| NDA 208341 | GILEAD SCIENCES INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 400MG;100MG | 1 | EPCLUSA | SOFOSBUVIR; VELPATASVIR |
| 002 | TABLET;ORAL | 200MG;50MG | 1 | EPCLUSA | SOFOSBUVIR; VELPATASVIR |
FDA Submissions
| TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 2016-06-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2017-02-14 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 7 | AP | 2017-08-31 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2017-11-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2019-09-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2020-03-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2020-07-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2021-06-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2022-04-27 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 31 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 2 |
| SUPPL | 17 | Orphan | 5 |
| SUPPL | 19 | Null | 6 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208341
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["",""]
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[supplements] => [{"actionDate":"07\/14\/2020","submission":"SUPPL-15","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208341s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208341Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"03\/19\/2020","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208341s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208341Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"09\/19\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208341s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208341Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"11\/15\/2019","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208341s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208341Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208341s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208341Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"08\/31\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208341s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208341Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"02\/14\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208341s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208341Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"08\/01\/2017","submission":"SUPPL-1","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208341s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/0208341Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-07-14
)
)