NDA 208624

ABBVIE INC

FDA Drug Application

Application #208624

Documents

• Label: 2016-07-25
• Letter: 2016-07-26
• Label: 2017-02-15
• Letter: 2017-02-15
• Label: 2017-03-23
• Label: 2017-03-23
• Letter: 2017-03-24
• Letter: 2017-03-24
• Review: 2017-06-28
• Label: 2017-11-13
• Letter: 2018-07-26
• Label: 2018-08-29
• Medication Guide: 2018-08-29
• Label: 2019-12-09
• Medication Guide: 2019-12-09
• Letter: 2019-12-10

Application Sponsors

NDA 208624

ABBVIE INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

EQ 200MG BASE;8.33MG;50MG;33.33MG

1

VIEKIRA XR

DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2016-07-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-02-14	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-03-22	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-11-09	STANDARD
LABELING; Labeling	SUPPL	6	AP	2018-07-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-12-06	STANDARD

Submissions Property Types

ORIG	1	Null	33
SUPPL	2	Null	15
SUPPL	3	Null	6
SUPPL	5	Null	6
SUPPL	6	Null	6
SUPPL	8	Null	15

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208624
            [companyName] => ABBVIE INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/208624s008lbl.pdf#page=49"]
            [products] => [{"drugName":"VIEKIRA XR","activeIngredients":"DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR","strength":"EQ 200MG BASE;8.33MG;50MG;33.33MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208624s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208624s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208624Orig1s005ltr.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208624s001s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208624s001s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208624s001s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208624s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208624s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/22\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208624s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208624Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208624Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208624s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208624Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/23\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208624s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208624Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208624Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"03\/22\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208624s001s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208624Orig1s001,208624Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"02\/14\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208624s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208624Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"03\/22\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208624s001s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208624Orig1s001,208624Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-12-06
        )

)