Application Nr Approved Date Route Status External Links
ANDA065021 1999-12-23 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage 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), S. 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.) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Amoxicillin Capsules, Amoxicillin Tablets, Amoxicillin Tablets (chewable) And Amoxicillin For Oral Suspension And Other Antibacterial Drugs, Amoxicillin Capsules, Amoxicillin Tablets, Amoxicillin Tablets (chewable) And Amoxicillin For Oral Suspension 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. Indicated Surgical Procedures Should Be Performed.

All Formulated Excipients (3 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

Active Ingredients ( 1 Total)

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

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