ANDA 206335, held by Eugia Pharma. Tigecycline.
As of Nov 15, 2026, ANDA 206335 (Tigecycline), held by Eugia Pharma, was first approved by FDA on Jun 11, 2019, 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 and other antibacterial drugs, tigecycline should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 11, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tigecycline50MG/VIAL · powder;intravenous | Tigecycline | Rx |
| Jan 24, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 24, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 11, 2019 | 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
