NDA 211158, held by Amneal. Tigecycline.
As of Nov 13, 2026, NDA 211158 (Tigecycline), held by Amneal, was first approved by FDA on Aug 2, 2018, with 4 approved supplements and 0 published complete response letters.
Tigecycline is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections Complicated intra-abdominal infections Community-acquired bacterial pneumonia Limitations of Use: Tigecycline for injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tigecycline for injection and other antibacterial drugs, tigecycline for injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tigecycline50MG/VIAL · powder;intravenous | Tigecycline | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2025 | Supplement 7Labeling · Standard review | Approved | |
| May 12, 2021 | Supplement 6Labeling · Standard review | Approved | |
| Nov 10, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Jul 31, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Aug 2, 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
