ANDA 208790, held by Acs Dobfar Spa. Ertapenem Sodium.
As of Nov 15, 2026, ANDA 208790 (Ertapenem Sodium), held by Acs Dobfar Spa, was first approved by FDA on Apr 16, 2018, with 4 approved supplements and 0 published complete response letters.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for Injection and other antibacterial drugs, Ertapenem for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ertapenem SodiumEQ 1GM BASE/VIAL · injectable;intramuscular, intravenous | Ertapenem Sodium | Rx |
| Aug 25, 2022 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 25, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Aug 21, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 21, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 16, 2018 | Original application | Approved |
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
