Application Nr Approved Date Route Status External Links
ANDA065191 2005-01-25 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Amoxicillin And Clavulanate Potassium Powder For Oral Suspension, Usp (amoxicillin/clavulanate Potassium) And Other Antibacterial Drugs, Amoxicillin And Clavulanate Potassium Powder For Oral Suspension, 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. Amoxicillin And Clavulanate Potassium Powder For Oral Suspension, Usp Is A Combination Penicillin-Class Antibacterial And Beta-Lactamase Inhibitor Indicated In The Treatment Of Infections Due To Susceptible Isolates Of The Designated Bacteria In The Conditions Listed Below*: Amoxicillin And Clavulanate Potassium Powder For Oral Suspension, Usp Is A Combination Penicillin-Class Antibacterial And Beta-Lactamase Inhibitor Indicated For Treatment Of The Following: Lower Respiratory Tract Infections (1.1) Acute Bacterial Otitis Media (1.2) Sinusitis (1.3) Skin And Skin Structure Infections (1.4) Urinary Tract Infections (1.5) 1.1 Lower Respiratory Tract Infections - Caused By Beta-Lactamase-Producing Isolates Of Haemophilus Influenzae And Moraxella Catarrhalis. 1.2 Acute Bacterial Otitis Media - Caused By Beta-Lactamase-Producing Isolates Of H. Influenzae And M. Catarrhalis. 1.3 Sinusitis - Caused By Beta-Lactamase-Producing Isolates Of H. Influenzae And M. Catarrhalis. 1.4 Skin And Skin Structure Infections - Caused By Beta-Lactamase-Producing Isolates Of Staphylococcus Aureus, Escherichia Coli, And Klebsiella Species. 1.5 Urinary Tract Infections - Caused By Beta-Lactamase-Producing Isolates Of E. Coli, Klebsiella Species, And Enterobacter Species. 1.6 Limitations Of Use - When Susceptibility Test Results Show Susceptibility To Amoxicillin, Indicating No Beta-Lactamase Production, Amoxicillin And Clavulanate Potassium Powder For Oral Suspension, Usp Should Not Be Used.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Aspartame ASPARTAME Molecular NUTRS-Nutritive Sweetener REG-Food additives for which a petition has been filed and a regulation issued.
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Succinic Acid SUCCINIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 2 Total)

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