Application Nr Approved Date Route Status External Links
ANDA090439 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Treatment Of: ( 1 ) C. Difficile -Associated Diarrhea Enterocolitis Caused By Staphylococcus Aureus (including Methicillin- Resistant Strains) Important Limitations: ( 1 ) ( 5.1 ) Orally Administered Vancomycin Hydrochloride Capsules Usp Is Not Effective For Other Types Of Infections. Vancomycin Hydrochloride Capsules Usp Are Indicated For The Treatment Of C. Difficile -Associated Diarrhea. Vancomycin Hydrochloride Capsules Usp Is Also Used For The Treatment Of Enterocolitis Caused By Staphylococcus Aureus (including Methicillin-Resistant Strains). Parenteral Administration Of Vancomycin Is Not Effective For The Above Infections; Therefore, Vancomycin Hydrochloride Capsules Usp Must Be Given Orally For These Infections. Orally Administered Vancomycin Hydrochloride Capsules Usp Is Not Effective For Other Types Of Infections. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Vancomycin Hydrochloride Capsules Usp And Other Antibacterial Drugs, Vancomycin Hydrochloride Capsules Usp Should Be Used Only To Treat 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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