ANDA 212040, held by Gland. Ertapenem Sodium.
As of Nov 15, 2026, ANDA 212040 (Ertapenem Sodium), held by Gland, was first approved by FDA on Mar 26, 2021, with 1 approved supplement 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 26, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ertapenem SodiumEQ 1GM BASE/VIAL · injectable;intramuscular, intravenous | Ertapenem Sodium | Rx |
| Aug 25, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 26, 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
