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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206619
Company: ABBVIE

Medication Guide

Summary Review

Products on NDA 206619

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIEKIRA PAK (COPACKAGED)	DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR	EQ 250MG BASE;12.5MG, 75MG, 50MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206619

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2014	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206619lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206619Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206619Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206619Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2019	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206619s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206619Orig1s020ltr.pdf
07/23/2018	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206619s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206619Orig1s018ltr.pdf
11/09/2017	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206619Orig1s017ltr.pdf
03/22/2017	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206619Orig1s013,206619Orig1s015ltr.pdf
02/14/2017	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206619Orig1s014ltr.pdf
03/22/2017	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206619Orig1s013,206619Orig1s015ltr.pdf
08/17/2016	SUPPL-12			Label is not available on this site.
06/21/2016	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s011ltr.pdf
01/28/2016	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s010ltr.pdf
04/22/2016	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s009ltr.pdf
10/22/2015	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s008ltr.pdf
09/22/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/13/2015	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s006ltr.pdf
07/20/2015	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s005ltr.pdf
07/30/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/25/2015	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s003ltr.pdf
07/09/2015	SUPPL-2	Labeling		Label is not available on this site.
06/19/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 206619

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206619s020lbl.pdf
07/23/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206619s018lbl.pdf
11/09/2017	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s017lbl.pdf
03/22/2017	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s013s015lbl.pdf
03/22/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s013s015lbl.pdf
03/22/2017	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s013s015lbl.pdf
02/14/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s014lbl.pdf
06/21/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619Orig1s011lbl.pdf
04/22/2016	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619s009lbl.pdf
01/28/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619s010lbl.pdf
10/22/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s008lbl.pdf
10/13/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s006lbl.pdf
07/20/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s005lbl.pdf
03/25/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s003lbl.pdf
03/25/2015	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s003lbl.pdf
12/19/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206619lbl.pdf

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