Application Nr Approved Date Route Status External Links
ANDA061667 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Vancomycin Hydrochloride For Oral Solution Is Administered Orally For Treatment Of Enterocolitis Caused By Staphylococcus Aureus (including Methicillin-Resistant Strains) And Antibiotic-Associated Pseudomembranous Colitis Caused By C. Difficile . Parenteral Administration Of Vancomycin Is Not Effective For The Above Indications; Therefore, Vancomycin Hydrochloride For Oral Solution Must Be Given Orally For These Infections. Orally Administered Vancomycin Hydrochloride For Oral Solution Is Not Effective For Other Types Of Infection. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Vancomycin Hydrochloride For Oral Solution And Other Antibacterial Drugs, Vancomycin Hydrochloride For Oral Solution Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Vancomycin Hydrochloride

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