Treats bacterial meningitis. NDA 215212, held by Hq Spclt Pharma. Meropenem.
As of Nov 13, 2026, NDA 215212 (Meropenem), held by Hq Spclt Pharma, was first approved by FDA on Jul 26, 2023, with 2 approved supplements and 1 published complete response letter.
Meropenem for Injection is a penem antibacterial indicated for the treatment of bacterial meningitis in pediatric patients 3 months of age and older only. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.1 Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Sep 14, 2021 | MeropenemNonclinical, Product Quality, Inical | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Meropenem2GM/VIAL · powder;intravenous | Meropenem | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 2026 | Supplement 1Labeling · Standard review | Approved | |
| Dec 3, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Jul 26, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
