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Data updated: Mar 10, 2026

AMPICILLIN AND SULBACTAM

AMPICILLIN SODIUM
Infectious Disease Approved 2002-03-19
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
15
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Prescription
First Approved
2002-03-19
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

EUGIA PHARMA SPECLTS ASTRAL ONESOURCE SPECIALTY HQ SPECLT PHARMA ISTITUTO BIO ITA SPA Hikma ACS DOBFAR Pfizer MEDIMETRIKS PHARMS Novartis ANTIBIOTICE
Active Ingredient: AMPICILLIN SODIUM , SULBACTAM SODIUM

AMPICILLIN AND SULBACTAM Approval History

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What AMPICILLIN AND SULBACTAM Treats

3 indications

AMPICILLIN 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
Source: FDA Label

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Trial Timeline

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Full development history with FDA approval milestones

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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

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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

FDA Approval: ANDA090339 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.