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Data updated: Mar 10, 2026

VANCOCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE
Infectious Disease Approved 1964-11-06
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
8
Indications
--
Phase 3 Trials
61
Years on Market

Details

Status
Prescription
First Approved
1964-11-06
Routes
ORAL, INJECTION
Dosage Forms
FOR SOLUTION, INJECTABLE, CAPSULE

Companies

ANI PHARMS STERISCIENCE
Active Ingredient: VANCOMYCIN HYDROCHLORIDE

VANCOCIN HYDROCHLORIDE Approval History

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What VANCOCIN HYDROCHLORIDE Treats

5 indications

VANCOCIN HYDROCHLORIDE is approved for 5 conditions since its original approval in 1964. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Staphylococcal Endocarditis
  • Septicemia
  • Bone Infection
  • Lower Respiratory Tract Infection
  • Skin Infection
Source: FDA Label

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5 shared
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Shared indications:
Staphylococcal EndocarditisSepticemiaBone Infection +2 more
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Bristol-Myers Squibb
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CEFAZOLIN AND DEXTROSE
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B BRAUN
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Shared indications:
Septicemia
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PAI HOLDINGS PHARM
Shared indications:
Lower Respiratory Tract Infection
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
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Shared indications:
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Shared indications:
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Trial Timeline

ClinicalTrials.gov β†— Pro

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.

VANCOCIN HYDROCHLORIDE FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (Ξ²-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci ...

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Data Sources

FDA Approval: ANDA061667 β†’ Label: DailyMed β†’ Patents: FDA Orange Book β†’ Trials: ClinicalTrials.gov β†’

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