Documents
Application Sponsors
| NDA 208464 | GILEAD SCIENCES INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | EQ 25MG BASE | 1 | VEMLIDY | TENOFOVIR ALAFENAMIDE FUMARATE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2016-11-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2018-07-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2019-02-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2020-02-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2020-08-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2020-08-18 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-09-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2022-10-17 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 10 | Null | 31 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 6 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208464
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["",""]
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[actionDate] => 2020-08-18
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