Application Nr Approved Date Route Status External Links
ANDA065096 2002-10-29 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/clavulanate Potassium And Other Antibacterial Drugs, Amoxicillin/clavulanate Potassium 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/clavulanate Potassium 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/clavulanate Potassium 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, Usp, Indicating No Beta-Lactamase Production, Amoxicillin/clavulanate Potassium Should Not Be Used.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 2 Total)

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