NDA 215973

GILEAD SCIENCES

FDA Drug Application

Application #215973

Documents

• Label: 2022-12-22
• Letter: 2022-12-23

Application Sponsors

NDA 215973

GILEAD SCIENCES

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

300MG

0

SUNLENCA

LENACAPAVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-12-22

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

GILEAD SCIENCES

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(
    [0] => Array
        (
            [ApplNo] => 215973
            [companyName] => GILEAD SCIENCES
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUNLENCA","activeIngredients":"LENACAPAVIR","strength":"300MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/22\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215973s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/22\/2022","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\\\/2022\\\/215973s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215973Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-12-22
        )

)