NDA 206843, held by Bristol-Myers Squibb. Daclatasvir Dihydrochloride.
As of Nov 14, 2026, NDA 206843 (Daklinza), held by Bristol-Myers Squibb, was first approved by FDA on Jul 24, 2015, with 8 approved supplements and 0 published complete response letters.
| Feb 5, 2016 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 5, 2016 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Feb 5, 2016 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jul 24, 2015 | Original applicationNew molecular entity · Priority review | Approved |
| DaklinzaEQ 30MG BASE · tablet;oral | Daclatasvir Dihydrochloride | DiscontinuedReference drug |
| DaklinzaEQ 60MG BASE · tablet;oral | Daclatasvir Dihydrochloride | DiscontinuedReference drug |
| DaklinzaEQ 90MG BASE · tablet;oral | Daclatasvir Dihydrochloride | DiscontinuedReference drug |
| Oct 16, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Nov 9, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Feb 14, 2017 | Supplement 6Labeling | Approved | |
| Dec 21, 2016 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Apr 13, 2016 | Supplement 4Manufacturing · Priority review | Approved | |
| Feb 5, 2016 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 5, 2016 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Feb 5, 2016 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jul 24, 2015 | Original applicationNew molecular entity · 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
