Documents
Application Sponsors
| NDA 203094 | GILEAD SCIENCES INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 150MG | 1 | TYBOST | COBICISTAT |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2014-09-24 | STANDARD |
| EFFICACY; Efficacy | ORIG | 2 | AP | 2014-09-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2015-11-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2016-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2016-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2017-05-04 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2017-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2018-07-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 2018-10-30 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2019-08-22 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2019-10-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 2020-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2021-09-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| ORIG | 2 | Null | 31 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Orphan | 5 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
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[0] => Array
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[actionDate] => 2019-10-03
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