NDA 208744, held by Accord Hlthcare Inc. Tigecycline.
As of Nov 13, 2026, NDA 208744 (Tigecycline), held by Accord Hlthcare Inc, was first approved by FDA on Jan 18, 2018, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tigecycline50MG/VIAL · powder;intravenous | Tigecycline | Discontinued |
| Mar 31, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Oct 21, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Jan 18, 2018 | Original applicationNew formulation or manufacturer · Standard 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
