GILEAD SCIENCES INC FDA Approval NDA 214187

NDA 214187

GILEAD SCIENCES INC

FDA Drug Application

Application #214187

Documents

Label2021-06-11
Letter2021-06-14

Application Sponsors

NDA 214187GILEAD SCIENCES INC

Marketing Status

Prescription001
Prescription002

Application Products

001PELLETS;ORAL200;50MG0EPCLUSASOFOSBUVIR;VELPATASVIR
002PELLETS;ORAL150;37.5MG0EPCLUSASOFOSBUVIR;VELPATASVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-06-10PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

GILEAD SCIENCES INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214187
            [companyName] => GILEAD SCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPCLUSA","activeIngredients":"SOFOSBUVIR;VELPATASVIR","strength":"200;50MG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"EPCLUSA","activeIngredients":"SOFOSBUVIR;VELPATASVIR","strength":"150;37.5MG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/10\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214187s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/10\/2021","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\\\/2021\\\/214187s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214187Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-10
        )

)

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