Documents
Application Sponsors
| NDA 214787 | GILEAD SCIENCES INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 5MG/ML | 2 | VEKLURY | REMDESIVIR |
| 002 | INJECTABLE;INJECTION | 100MG/VIAL | 2 | VEKLURY | REMDESIVIR |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-10-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-02-22 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-01-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2022-01-21 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2022-04-25 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2022-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2022-09-29 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2022-06-24 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2022-10-24 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2022-12-15 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 20 | Null | 6 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 214787
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["",""]
[products] => [{"drugName":"VEKLURY","activeIngredients":"REMDESIVIR","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"VEKLURY","activeIngredients":"REMDESIVIR","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"10\/22\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214787Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214787Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214787Orig1s000ltr.pdf\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/214787Orig1s000Sumr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-10-22
)
)