MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
Details
- Status
- Prescription
- First Approved
- 2015-04-30
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER Approval History
What MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER Treats
3 indicationsMEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Skin and Skin Structure Infections
- Intra-abdominal Infections
- Bacterial Meningitis
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER FDA Label Details
ProIndications & Usage
FDA Label (PDF)Meropenem for Injection, USP 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 only). Complicated intra-abdominal infections (adult and pediatric patients). Bacterial meningitis (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, USP and other antibacterial drugs, Meropenem for Injection, USP should only be used to treat or prevent infections that are proven or stro...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.