AMPICILLIN AND SULBACTAM (ampicillin sodium) · ASTRAL
Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus , Escherichia coli ,* Klebsiella spp.* (including K. pneumoniae *), Proteus mirabilis ,* Bacteroides fragilis ,* Enterobacter spp.,* and Acinetobacter calcoaceticus .
Details
- Status
- Discontinued
- First Approved
- 2002-03-19
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AMPICILLIN AND SULBACTAM Approval History
What AMPICILLIN AND SULBACTAM Treats
3 indicationsAMPICILLIN AND SULBACTAM is approved for 3 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Skin and Skin Structure Infections
- Intra-Abdominal Infections
- Gynecological Infections
AMPICILLIN AND SULBACTAM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
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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.
AMPICILLIN AND SULBACTAM FDA Label Details
Indications & Usage
Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus , Escherichia coli ,* Klebsiella spp.* (including K. pneumoniae *), Proteus mirabilis ,* Bacteroides fragilis ,* Enterobacter spp.,* and Acinetobacter calcoaceticus .* NOTE: For information on use in pediatric patients (see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by be...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.