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FDA NDA · NDA208624

VIEKIRA XR

Sponsor: ABBVIE

APPLICATION
NDA208624
TYPE
NDA
ORIGINAL APPROVAL
2016-07-22
LATEST ACTION
2019-12-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

VIEKIRA XR · ReferenceDiscontinued
DASABUVIR SODIUM EQ 200MG BASE, OMBITASVIR 8.33MG, PARITAPREVIR 50MG, RITONAVIR 33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-12-06Labeling · Supplement 8 · standard — Label ↗AP
2018-07-23Labeling · Supplement 6 · standard — Letter ↗AP
2017-11-09Labeling · Supplement 5 · standard — Label ↗AP
2017-03-22Labeling · Supplement 3 · standard — Label ↗AP
2017-03-22Labeling · Supplement 1 · standard — Label ↗AP
2017-02-14Labeling · Supplement 2 · standard — Label ↗AP
2016-07-22Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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