Application Nr Approved Date Route Status External Links
ANDA064082 1995-08-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ampicillin Capsules, Usp Are Indicated In The Treatment Of Infections Caused By Susceptible Strains Of The Designated Organism Listed Below: Infections Of The Genitourinary Tract Including Gonorrhea: E. Coli, P. Mirabilis, Enterococci, Shigella , S. Typhosa And Other Salmonella, And Nonpenicillinase Producing N. Gonorrhoeae. Infections Of The Respiratory Tract: Nonpenicillinase- Producing H. Influenzae And Staphylococci, And Streptococci Including Streptococcus Pneumoniae. Infections Of The Gastrointestinal Tract: Shigella, S. Typhosa And Other Salmonella, E. Coli, P. Mirabilis, And Enterococci. Meningitis: N. Meningitides. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Ampicillin And Other Antibacterial Drugs, Ampicillin 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. Bacteriology Studies To Determine The Causative Organisms And Their Susceptibility To Ampicillin Should Be Performed. Therapy May Be Instituted Prior To The Results Of Susceptibility Testing.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
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
5. Shellac SHELLAC Unresolved
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Ammonia AMMONIA Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ampicillin Trihydrate AMPICILLIN TRIHYDRATE ZINC3830218

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