Application Nr Approved Date Route Status External Links
ANDA065311 2006-02-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Cefadroxil Capsules, Usp Are Indicated For The Treatment Of Patients With Infection Caused By Susceptible Strains Of The Designated Organisms In The Following Diseases: Urinary Tract Infections Caused By E. Coli, P. Mirabilis, And Klebsiella Species. Skin And Skin Structure Infections Caused By Staphylococci And/or Streptococci. Pharyngitis And/or Tonsillitis Caused By Streptococcus Pyogenes (group A Beta-Hemolytic Streptococci). Note: Only Penicillin By The Intramuscular Route Of Administration Has Been Shown To Be Effective In The Prophylaxis Of Rheumatic Fever. Cefadroxil Is Generally Effective In The Eradication Of Streptococci From The Oropharynx. However, Data Establishing The Efficacy Of Cefadroxil For The Prophylaxis Of Subsequent Rheumatic Fever Are Not Available. Note: Culture And Susceptibility Tests Should Be Initiated Prior To And During Therapy. Renal Function Studies Should Be Performed When Indicated. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cefadroxil Capsules, Usp And Other Antibacterial Drugs, Cefadroxil Capsules, 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 (7 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Gelatin GELATIN Unresolved
5. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
6. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Ferric Oxide Red FERRIC OXIDE RED Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cefadroxil CEFADROXIL ZINC3830391

Comments