NDA 215413

VIIV HLTHCARE

FDA Drug Application

Application #215413

Documents

• Letter: 2022-03-31
• Label: 2022-03-31
• Medication Guide: 2022-03-31
• Review: 2022-05-12
• Letter: 2022-10-11
• Label: 2022-10-11
• Medication Guide: 2022-10-11

Application Sponsors

NDA 215413

VIIV HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET, FOR SUSPENSION; ORAL

EQ 60MG BASE; 5MG; 30MG

0

TRIUMEQ PD

ABACAVIR DOLUTEGRAVIR LAMIVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-03-30

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

VIIV HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215413
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/215413s000lbl.pdf#page=53"]
            [products] => [{"drugName":"TRIUMEQ PD","activeIngredients":"ABACAVIR DOLUTEGRAVIR LAMIVUDINE","strength":"EQ 60MG BASE; 5MG; 30MG","dosageForm":"TABLET, FOR SUSPENSION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/30\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215413s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/30\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215413s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215413Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-03-30
        )

)