Documents
Application Sponsors
| NDA 022577 | GILEAD SCIENCES INC | |
Marketing Status
Application Products
| 001 | POWDER;ORAL | 40MG/SCOOPFUL | 1 | VIREAD | TENOFOVIR DISOPROXIL FUMARATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2012-01-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2012-08-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2013-07-24 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-04-02 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2013-10-23 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2015-05-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2015-12-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2016-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2017-04-07 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2018-07-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2018-12-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 14 | AP | 2019-04-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Orphan | 5 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 22577
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["",""]
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[originalApprovals] => [{"actionDate":"VIREAD","submission":"TENOFOVIR DISOPROXIL FUMARATE","actionType":"40MG\/SCOOPFUL","submissionClassification":"POWDER;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-04-24
)
)