Application Nr Approved Date Route Status External Links
ANDA065145 2004-06-24 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Adults (clarithromycin Extended-Release Tablets, Usp) Clarithromycin Extended-Release Tablets, Usp Are Indicated For The Treatment Of Adults With Mild To Moderate Infection Caused By Susceptible Strains Of The Designated Microorganisms In The Conditions Listed Below: Acute Maxillary Sinusitis Due To Haemophilus Influenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae. Acute Bacterial Exacerbation Of Chronic Bronchitis Due To Haemophilus Influenzae, Haemophilus Parainfluenzae, Moraxella Catarrhalis, Or Streptococcus Pneumoniae. Community-Acquired Pneumonia Due To Haemophilus Influenzae, Haemophilus Parainfluenzae, Moraxella Catarrhalis, Streptococcus Pneumoniae, Chlamydophila Pneumoniae (twar), Or Mycoplasma Pneumoniae. The Efficacy And Safety Of Clarithromycin Extended-Release Tablets, Usp In Treating Other Infections For Which Other Formulations Of Clarithromycin Are Approved Have Not Been Established. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Clarithromycin Extended-Release Tablets, Usp And Other Antibacterial Drugs, Clarithromycin Extended-Release Tablets, Usp 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 (4 Total)

Name Structure Kind Function Status
1. Compressible Sugar COMPRESSIBLE SUGAR Molecular
2. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
3. Polyethylene Glycol 3000 POLYETHYLENE GLYCOL 3000 Unresolved
4. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clarithromycin CLARITHROMYCIN ZINC85534098

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