Application Nr Approved Date Route Status External Links
ANDA065093 2002-11-21 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 And Other Antibacterial Drugs, Amoxicillin And 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 And 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 And 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, Indicating No Beta-Lactamase Production, Amoxicillin And Clavulanate Potassium Should Not Be Used.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Ethylcelluloses ETHYLCELLULOSES Unresolved
2. 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.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
5. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
6. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
7. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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