NDA 212950

VIIV HLTHCARE

FDA Drug Application

Application #212950

Documents

• Label: 2020-07-06
• Letter: 2020-07-06
• Review: 2020-07-29
• Letter: 2022-02-03

Application Sponsors

NDA 212950

VIIV HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

600MG

2

RUKOBIA

FOSTEMSAVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-07-02	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2022-01-24	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6

CDER Filings

VIIV HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212950
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUKOBIA","activeIngredients":"FOSTEMSAVIR","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"07\/02\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212950s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/02\/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\\\/212950s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212950Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-02
        )

)