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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208624
Company: ABBVIE

Medication Guide

Products on NDA 208624

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIEKIRA XR	DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR	EQ 200MG BASE;8.33MG;50MG;33.33MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208624

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/22/2016	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208624s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208624Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208624Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208624s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208624Orig1s008ltr.pdf
07/23/2018	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208624s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208624Orig1s006ltr.pdf
11/09/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624Orig1s005ltr.pdf
03/22/2017	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s001,208624Orig1s003ltr.pdf
02/14/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s002ltr.pdf
03/22/2017	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s001,208624Orig1s003ltr.pdf

Labels for NDA 208624

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208624s008lbl.pdf
07/23/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208624s006lbl.pdf
11/09/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624Orig1s005ltr.pdf
03/22/2017	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf
03/22/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf
03/22/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf
02/14/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s002lbl.pdf
07/22/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208624s000lbl.pdf

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