OMNIPEN-N (ampicillin sodium) · Pfizer
OMNIPEN-N is FDA-approved to treat 8 conditions (same as AMPICILLIN SODIUM).
Details
- Status
- Discontinued
- First Approved
- N/A
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OMNIPEN-N Approval History
What OMNIPEN-N Treats
8 indicationsOMNIPEN-N is approved for 8 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
- Respiratory Tract Infection
- Bacterial Meningitis
- Septicemia
- Endocarditis
- Urinary Tract Infection
- Gastrointestinal Infection
- Typhoid Fever
- Dysentery
Same approved indications as AMPICILLIN SODIUM (same active ingredient).
Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
OMNIPEN-N FDA Label Details
Indications & Usage
OMNIPEN-N is FDA-approved to treat 8 conditions — same approved indications as AMPICILLIN SODIUM.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.