NDA 208984

VIIV HLTHCARE

FDA Drug Application

Application #208984

Documents

• Label: 2016-11-08
• Letter: 2016-11-09
• Review: 2017-10-26
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Label: 2018-07-19
• Medication Guide: 2018-07-19
• Letter: 2018-07-20
• Letter: 2020-11-03
• Label: 2020-11-03
• Medication Guide: 2020-11-03

Application Sponsors

NDA 208984

VIIV HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

20MG/ML

1

SELZENTRY

MARAVIROC

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2016-11-04	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2020-10-30	PRIORITY

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

VIIV HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208984
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/022128s019,208984s002lbl.pdf#page=43"]
            [products] => [{"drugName":"SELZENTRY","activeIngredients":"MARAVIROC","strength":"20MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/30\/2020","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022128s019,208984s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022128s018,208984s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208984_022128s017lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/04\/2016","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\\\/2016\\\/208984_022128s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208984Orig1s000,022128Orig1s17ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208984Orig1s000,022128Orig1s017TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/30\/2020","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022128s019,208984s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/18\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022128s018,208984s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/022128Orig1s018,208984Orig1s001Ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-10-30
        )

)