Viekira Pak (Copackaged)

NDA 206619, held by Abbvie. Dasabuvir Sodium; Ombitasvir, Paritaprevir, Ritonavir.

As of Nov 14, 2026, NDA 206619 (Viekira Pak (Copackaged)), held by Abbvie, was first approved by FDA on Dec 19, 2014, with 18 approved supplements and 0 published complete response letters.

First approved: Dec 19, 2014
Review: Priority
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Apr 22, 2016	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 19, 2014	Original applicationNew molecular entity, new combination · Priority review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Viekira Pak (Copackaged)EQ 250MG BASE;12.5MG, 75MG, 50MG · tablet;oral	Dasabuvir Sodium; Ombitasvir, Paritaprevir, Ritonavir	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Dec 6, 2019	Supplement 20Labeling · Standard review	Approved	Letter Label Medication Guide
Jul 23, 2018	Supplement 18Labeling · Standard review	Approved	Label Medication Guide Letter
Nov 9, 2017	Supplement 17Labeling · Standard review	Approved	Letter Label
Mar 22, 2017	Supplement 13Labeling · Standard review	Approved	Letter Label
Mar 22, 2017	Supplement 15Labeling · Standard review	Approved	Letter Label
Feb 14, 2017	Supplement 14Labeling · Standard review	Approved	Label Letter
Aug 17, 2016	Supplement 12Manufacturing	Approved	None posted
Jun 21, 2016	Supplement 11Labeling · Standard review	Approved	Letter Label
Apr 22, 2016	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 28, 2016	Supplement 10Labeling · Standard review	Approved	Label Letter
Oct 22, 2015	Supplement 8Labeling · Standard review	Approved	Letter Label
Oct 13, 2015	Supplement 6Labeling · Standard review	Approved	Label Letter
Sep 22, 2015	Supplement 7Manufacturing · Priority review	Approved	None posted
Jul 30, 2015	Supplement 4Manufacturing · Priority review	Approved	None posted
Jul 20, 2015	Supplement 5Labeling · Standard review	Approved	Letter Label
Jul 9, 2015	Supplement 2Labeling · Priority review	Approved	None posted
Jun 19, 2015	Supplement 1Manufacturing · Priority review	Approved	None posted
Mar 25, 2015	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 19, 2014	Original applicationNew molecular entity, new combination · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 206619
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters