ANDA 207647, held by Savior Lifetec Corp. Ertapenem Sodium.
As of Nov 15, 2026, ANDA 207647 (Ertapenem Sodium), held by Savior Lifetec Corp, was first approved by FDA on Mar 19, 2019, with 2 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 |
|---|---|---|---|
| Mar 19, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ertapenem SodiumEQ 1GM BASE/VIAL · injectable;intramuscular, intravenous | Ertapenem Sodium | Rx |
| Feb 8, 2022 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jun 9, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 19, 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
