Documents
Application Sponsors
| NDA 208351 | GILEAD SCIENCES INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 200MG;EQ 25MG BASE;EQ 25MG BASE | 1 | ODEFSEY | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2016-03-01 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2017-08-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2017-08-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2018-10-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2019-12-03 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-09-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 13 | Null | 7 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208351
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["",""]
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[actionDate] => 2019-12-03
)
)