ANDA 214020, held by Meitheal. Tigecycline.
As of Nov 15, 2026, ANDA 214020 (Tigecycline), held by Meitheal, was first approved by FDA on May 13, 2021, with 1 approved supplement 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 |
|---|---|---|---|
| May 13, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tigecycline50MG/VIAL · powder;intravenous | Tigecycline | Rx |
| Sep 15, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 13, 2021 | 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
