Application Nr Approved Date Route Status External Links
ANDA065291 2007-02-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Amoxicillin And Other Antibacterial Drugs, Amoxicillin 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. Amoxicillin Is Indicated In The Treatment Of Infections Due To Susceptible (only Β-Lactamase–negative) Strains Of The Designated Microorganisms In The Conditions Listed Below: Infections Of The Ear, Nose, And Throat –due To Streptococcus Spp. (α- And Β-Hemolytic Strains Only), Streptococcus Pneumoniae, Staphylococcus Spp., Or H. Influenzae. Infections Of The Genitourinary Tract – Due To E. Coli, P. Mirabilis, Or E. Faecalis. Infections Of The Skin And Skin Structure – Due To Streptococcus Spp. (α- And Β-Hemolytic Strains Only), Staphylococcus Spp., Or E. Coli. Infections Of The Lower Respiratory Tract Due To Streptococcus Spp. (α- And Β-Hemolytic Strains Only), S. Pneumoniae, Staphylococcus Spp., Or H. Influenzae. Gonorrhea, Acute Uncomplicated (ano-Genital And Urethral Infections) Due To N. Gonorrhoeae (males And Females). H. Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence Triple Therapy: Amoxicillin /clarithromycin/lansoprazole Amoxicillin, In Combination With Clarithromycin Plus Lansoprazole As Triple Therapy, Is Indicated For The Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease (active Or 1-Year History Of A Duodenal Ulcer) To Eradicate H. Pylori. Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence. (see Clinical Studies And Dosage And Administration.) Dual Therapy: Amoxicillin/lansoprazole Amoxicillin, In Combination With Lansoprazole Delayed-Release Capsules As Dual Therapy, Is Indicated For The Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease (active Or 1-Year History Of A Duodenal Ulcer) Who Are Either Allergic Or Intolerant To Clarithromycin Or In Whom Resistance To Clarithromycin Is Known Or Suspected. (see The Clarithromycin Package Insert, Microbiology.) Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence. (see Clinical Studies And Dosage And Administration.) Indicated Surgical Procedures Should Be Performed.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Gelatin GELATIN 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. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Amoxicillin AMOXICILLIN ZINC3830215

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