Documents
Application Sponsors
| NDA 212480 | GILEAD SCIENCES INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | PELLETS;ORAL | 150MG/PACKET | 1 | SOVALDI | SOFOSBUVIR |
| 002 | PELLETS;ORAL | 200MG/PACKET | 1 | SOVALDI | SOFOSBUVIR |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2019-08-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-12-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 6 |
CDER Filings
GILEAD SCIENCES INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212480
[companyName] => GILEAD SCIENCES INC
[docInserts] => ["",""]
[products] => [{"drugName":"SOVALDI","activeIngredients":"SOFOSBUVIR","strength":"150MG\/PACKET","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SOVALDI","activeIngredients":"SOFOSBUVIR","strength":"200MG\/PACKET","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/05\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204671s017,212480s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204671s017,212480s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204671s016,212480s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212480s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212480s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212480Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212480Orig1s003ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/05\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204671s017,212480s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"09\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204671s016,212480s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204671Orig1s016,%20212480Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-03-05
)
)