NDA 205645, held by Fresenius Kabi USA. Tigecycline.
As of Nov 13, 2026, NDA 205645 (Tigecycline), held by Fresenius Kabi USA, was first approved by FDA on Dec 1, 2016, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 1, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tigecycline50MG/VIAL · powder;intravenous | Tigecycline | DiscontinuedReference drug |
| Mar 31, 2025 | Supplement 13Labeling · Standard review | Approved | |
| Nov 16, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Apr 4, 2019 | Supplement 3Labeling · Standard review | Approved | |
| Aug 15, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Dec 1, 2016 | 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
