NDA 212887

VIIV HLTHCARE

FDA Drug Application

Application #212887

Documents

• Letter: 2021-01-22
• Label: 2021-02-12
• Review: 2021-03-03
• Label: 2021-12-21
• Letter: 2021-12-22
• Letter: 2022-02-01
• Label: 2022-02-03
• Letter: 2022-02-08
• Label: 2022-02-10
• Letter: 2022-03-24
• Label: 2022-03-25
• Letter: 2022-03-30
• Letter: 2022-03-30
• Label: 2022-03-30
• Label: 2022-03-30

Application Sponsors

NDA 212887

VIIV HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET, FILM COATED

30MG

0

VOCABRIA

CABOTEGRAVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-01-21	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2022-02-07	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2022-03-23	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2021-12-20	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2022-03-29	PRIORITY
EFFICACY; Efficacy	SUPPL	6	AP	2022-03-29	PRIORITY

Submissions Property Types

ORIG	1	Null	33
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	5	Null	7
SUPPL	6	Null	15

CDER Filings

VIIV HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212887
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VOCABRIA","activeIngredients":"CABOTEGRAVIR","strength":"30MG","dosageForm":"TABLET, FILM COATED","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212887Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-21
        )

)