← FDA DRUG APPROVALS

FDA NDA · NDA206619

VIEKIRA PAK (COPACKAGED)

Sponsor: ABBVIE

APPLICATION
NDA206619
TYPE
NDA
ORIGINAL APPROVAL
2014-12-19
LATEST ACTION
2019-12-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VIEKIRA PAK (COPACKAGED) · ReferenceDiscontinued
DASABUVIR SODIUM EQ 250MG BASE, OMBITASVIR, PARITAPREVIR, RITONAVIR 12.5MG, 75MG, 50MG · TABLET · ORAL

Approval history

2019-12-06Labeling · Supplement 20 · standard — Label ↗AP
2018-07-23Labeling · Supplement 18 · standard — Letter ↗AP
2017-11-09Labeling · Supplement 17 · standard — Letter ↗AP
2017-03-22Labeling · Supplement 15 · standard — Label ↗AP
2017-03-22Labeling · Supplement 13 · standard — Label ↗AP
2017-02-14Labeling · Supplement 14 · standard — Label ↗AP
2016-08-17Manufacturing (CMC) · Supplement 12 · unknownAP
2016-06-21Labeling · Supplement 11 · standard — Label ↗AP
2016-04-22Efficacy · Supplement 9 · priority — Label ↗AP
2016-01-28Labeling · Supplement 10 · standard — Label ↗AP
2015-10-22Labeling · Supplement 8 · standard — Label ↗AP
2015-10-13Labeling · Supplement 6 · standard — Label ↗AP
2015-09-22Manufacturing (CMC) · Supplement 7 · priorityAP
2015-07-30Manufacturing (CMC) · Supplement 4 · priorityAP
2015-07-20Labeling · Supplement 5 · standard — Letter ↗AP
2015-07-09Labeling · Supplement 2 · priorityAP
2015-06-19Manufacturing (CMC) · Supplement 1 · priorityAP
2015-03-25Labeling · Supplement 3 · standard — Label ↗AP
2014-12-19Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
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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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