ANDA 209145, held by Sun Pharm. Ertapenem Sodium.
As of Nov 15, 2026, ANDA 209145 (Ertapenem Sodium), held by Sun Pharm, was first approved by FDA on May 2, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 2, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ertapenem SodiumEQ 1GM BASE/VIAL ยท injectable;intramuscular, intravenous | Ertapenem Sodium | Discontinued |
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
