Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206619
Company: ABBVIE INC
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,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG TABLET, TABLET;ORAL Prescription None Yes Yes
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
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-Medication Guide, Labeling-Package Insert 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s003lbl.pdf
03/25/2015 SUPPL-3 Labeling-Package Insert 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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