Treats complicated skin and skin structure infections (cSSSI) due to Staphylococcus…. NDA 202106, held by B Braun Medical. Meropenem.
As of Nov 13, 2026, NDA 202106 (Meropenem And Sodium Chloride In Duplex Container), held by B Braun Medical, was first approved by FDA on Apr 30, 2015, with 4 approved supplements and 0 published complete response letters.
Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2015 | Original applicationNew combination · Standard review | Approved |
| Dec 3, 2024 | Supplement 9Labeling · Standard review | Approved | |
| May 12, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Jan 19, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Dec 15, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 30, 2015 | Original applicationNew combination · Standard review | 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
