GILEAD SCIENCES INC FDA Approval NDA 214787

NDA 214787

GILEAD SCIENCES INC

FDA Drug Application

Application #214787

Documents

Summary Review2020-10-22
Letter2020-10-22
Label2020-10-22

Application Sponsors

NDA 214787GILEAD SCIENCES INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION5MG/ML2VEKLURYREMDESIVIR
002INJECTABLE;INJECTION100MG/VIAL2VEKLURYREMDESIVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-10-22PRIORITY

Submissions Property Types

ORIG1Null2

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
        )

)

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