Documents
Application Sponsors
| NDA 205834 | GILEAD SCIENCES INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 90MG;400MG | 1 | HARVONI | LEDIPASVIR; SOFOSBUVIR |
| 002 | TABLET;ORAL | 45MG;200MG | 1 | HARVONI | LEDIPASVIR; SOFOSBUVIR |
FDA Submissions
| TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 2014-10-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2015-11-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2015-11-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2015-11-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2015-11-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2015-11-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2016-02-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2016-02-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2016-02-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 2016-06-08 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2016-02-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2016-06-22 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2017-04-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 18 | AP | 2017-02-14 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 24 | AP | 2017-11-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 2019-11-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2019-08-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 31 | AP | 2019-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2020-03-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 32 | Null | 15 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205834
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["",""]
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[actionDate] => 2020-03-05
)
)