ANDA 204439, held by Apotex. Tigecycline.
As of Nov 15, 2026, ANDA 204439 (Tigecycline), held by Apotex, was first approved by FDA on Dec 21, 2018, with 2 approved supplements and 0 published complete response letters.
Tigecycline for injection 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 |
|---|---|---|---|
| Dec 21, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tigecycline50MG/VIAL · powder;intravenous | Tigecycline | Rx |
| Aug 6, 2025 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 1, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 21, 2018 | Original application | Approved | None posted |
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
