NDA 215499

VIIV HLTHCARE

FDA Drug Application

Application #215499

Documents

• Label: 2021-12-20
• Letter: 2021-12-22
• Review: 2022-09-09

Application Sponsors

NDA 215499

VIIV HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

600MG/3ML (200MG/ML)

2

APRETUDE

CABOTEGRAVIR

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-12-20

PRIORITY

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

TBD

CDER Filings

VIIV HLTHCARE

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(
    [0] => Array
        (
            [ApplNo] => 215499
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"APRETUDE","activeIngredients":"CABOTEGRAVIR","strength":"600MG\/3ML (200MG\/ML)","dosageForm":"FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/20\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215499s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215499s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215499Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-20
        )

)