Application Nr Approved Date Route Status External Links
ANDA065368 2007-05-09 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 Cefdinir Capsules And Other Antibacterial Drugs, Cefdinir Capsules 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. Cefdinir Capsules Are Indicated For The Treatment Of Patients With Mild To Moderate Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Conditions Listed Below. Adults And Adolescents Community-Acquired Pneumonia Caused By Haemophilus Influenzae (including Β-Lactamase Producing Strains), Haemophilus Parainfluenzae (including Β-Lactamase Producing Strains), Streptococcus Pneumoniae (penicillin-Susceptible Strains Only), And Moraxella Catarrhalis (including Β-Lactamase Producing Strains) (see Clinical Studies). Acute Exacerbations Of Chronic Bronchitis Caused By Haemophilus Influenzae (including Β-Lactamase Producing Strains), Haemophilus Parainfluenzae (including Β-Lactamase Producing Strains), Streptococcus Pneumoniae (penicillin-Susceptible Strains Only), And Moraxella Catarrhalis (including Β-Lactamase Producing Strains). Acute Maxillary Sinusitis Caused By Haemophilus Influenzae (including Β-Lactamase Producing Strains), Streptococcus Pneumoniae (penicillin-Susceptible Strains Only), And Moraxella Catarrhalis (including Β-Lactamase Producing Strains). Note: For Information On Use In Pediatric Patients, See Pediatric Use And Dosage Andadministration. Pharyngitis/tonsillitis Caused By Streptococcus Pyogenes (see Clinical Studies). Note: Cefdinir Is Effective In The Eradication Of S. Pyogenes From The Oropharynx. Cefdinir Has Not, However, Been Studied For The Prevention Of Rheumatic Fever Following S. Pyogenes Pharyngitis/tonsillitis. Only Intramuscular Penicillin Has Been Demonstrated To Be Effective For The Prevention Of Rheumatic Fever. Uncomplicated Skin And Skin Structure Infections Caused By Staphylococcus Aureus (including Β-Lactamase Producing Strains) And Streptococcus Pyogenes. Pediatric Patients Acute Bacterial Otitis Media Caused By Haemophilus Influenzae (including Β-Lactamase Producing Strains), Streptococcus Pneumoniae (penicillin-Susceptible Strains Only), And Moraxella Catarrhalis (including Β-Lactamase Producing Strains). Pharyngitis/tonsillitis Caused By Streptococcus Pyogenes (see Clinical Studies). Note: Cefdinir Is Effective In The Eradication Of S. Pyogenes From The Oropharynx. Cefdinir Has Not, However, Been Studied For The Prevention Of Rheumatic Fever Following S. Pyogenes Pharyngitis/tonsillitis. Only Intramuscular Penicillin Has Been Demonstrated To Be Effective For The Prevention Of Rheumatic Fever. Uncomplicated Skin And Skin Structure Infections Caused By Staphylococcus Aureus (including Β-Lactamase Producing Strains) And Streptococcus Pyogenes.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Carboxymethylcellulose Calcium CARBOXYMETHYLCELLULOSE CALCIUM Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Gelatin GELATIN Unresolved
5. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
6. 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.
7. Polyoxyl 40 Stearate POLYOXYL 40 STEARATE Unresolved
8. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cefdinir CEFDINIR ZINC3927198

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