Documents
Application Sponsors
| NDA 210251 | GILEAD SCIENCES INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 50MG BASE;200MG;EQ 25MG BASE | 1 | BIKTARVY | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
| 002 | TABLET;ORAL | EQ 30MG BASE;120MG;EQ 15MG BASE | 2 | BIKTARVY | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
FDA Submissions
| TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 2018-02-07 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2019-06-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-08-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2021-02-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2021-02-24 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-02-11 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-09-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2021-10-07 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2022-10-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 8 |
| SUPPL | 15 | Null | 6 |
TE Codes
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210251
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["",""]
[products] => [{"drugName":"BIKTARVY","activeIngredients":"BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","strength":"EQ 50MG BASE;200MG;EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/02\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210251s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210251s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210251s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"02\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210251s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210251Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210251Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/02\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210251s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210251Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"06\/18\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210251s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210251Orig1s005ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-08-02
)
)