Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207931
Company: ABBVIE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNIVIE OMBITASVIR; PARITAPREVIR; RITONAVIR 12.5MG;75MG;50MG 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
07/24/2015 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207931Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207931Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/22/2017 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s007,207931Orig1s009ltr.pdf
02/14/2017 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s008ltr.pdf
03/22/2017 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s007,207931Orig1s009ltr.pdf
02/24/2017 SUPPL-6 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207931Orig1s006Replacementltr.pdf
06/22/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207931Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207931Orig1s004ltr.pdf
01/28/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207931s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207931Orig1s002ltr.pdf
10/22/2015 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207931Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/22/2017 SUPPL-9 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf
03/22/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf
03/22/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s007s009lbl.pdf
02/24/2017 SUPPL-6 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s006lbl.pdf
02/14/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207931s008lbl.pdf
06/22/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207931Orig1s004lbl.pdf
01/28/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207931s002lbl.pdf
10/22/2015 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931s001lbl.pdf
07/24/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931Orig1s000lbl.pdf

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