ANDA 209133, held by Eugia Pharma. Ertapenem Sodium.
As of Nov 15, 2026, ANDA 209133 (Ertapenem Sodium), held by Eugia Pharma, was first approved by FDA on Jun 25, 2018, with 5 approved supplements and 0 published complete response letters.
Ertapenem for injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. Community-acquired pneumonia. Complicated urinary tract infections including pyelonephritis. Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ertapenem SodiumEQ 1GM BASE/VIAL · injectable;intramuscular, intravenous | Ertapenem Sodium | Rx |
| Jun 13, 2024 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jan 27, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 27, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 9, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 30, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 25, 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
