NDA 207931, held by Abbvie. Ombitasvir; Paritaprevir; Ritonavir.
As of Nov 14, 2026, NDA 207931 (Technivie), held by Abbvie, was first approved by FDA on Jul 24, 2015, with 10 approved supplements and 0 published complete response letters.
| Feb 24, 2017 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2015 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Technivie12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ombitasvir; Paritaprevir; Ritonavir | DiscontinuedReference drug |
| Dec 6, 2019 | Supplement 13Labeling · Standard review | Approved | |
| Jul 23, 2018 | Supplement 12Labeling · Standard review | Approved | |
| Nov 9, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Mar 22, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Mar 22, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Feb 24, 2017 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Feb 14, 2017 | Supplement 8Labeling · Standard review | Approved | |
| Jun 22, 2016 | Supplement 4Labeling · Standard review | Approved | |
| Jan 28, 2016 | Supplement 2Labeling · Standard review | Approved | |
| Oct 22, 2015 | Supplement 1Labeling · Standard review | Approved | |
| Jul 24, 2015 | Original applicationNew formulation or manufacturer · Priority review | Approved |
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
