Documents
Application Sponsors
| NDA 207561 | GILEAD SCIENCES INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 150MG;150MG;200MG;EQ 10MG BASE | 1 | GENVOYA | COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
FDA Submissions
| TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 2015-11-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2016-12-07 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2016-03-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2017-02-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2017-02-15 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2016-09-15 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 10 | AP | 2017-04-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2017-08-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2017-11-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2017-09-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 2018-08-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2018-12-10 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2018-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2019-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2020-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2021-09-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2022-01-07 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 29 | Null | 7 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207561
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["",""]
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[supplements] => [{"actionDate":"12\/02\/2020","submission":"SUPPL-24","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207561s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207561Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"03\/18\/2019","submission":"SUPPL-23","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207561s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207561Orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"11\/02\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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[actionDate] => 2020-12-02
)
)