Application Nr Approved Date Route Status External Links
ANDA065229 2005-11-25 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Cephalexin Capsules Usp Is A Cephalosporin Antibacterial Drug Indicated For The Treatment Of The Following Infections Caused By Susceptible Isolates Of Designated Bacteria: Respiratory Tract Infection (1.1) Otitis Media (1.2) Skin And Skin Structure Infections (1.3) Bone Infections (1.4) Genitourinary Tract Infections (1.5) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cephalexin Capsules Usp And Other Antibacterial Drugs, Cephalexin Capsules Usp Should Be Used Only To Treat Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria. (1.6) 1.1 Respiratory Tract Infections Cephalexin Capsules Usp Are Indicated For The Treatment Of Respiratory Tract Infections Caused By Susceptible Isolates Of Streptococcus Pneumoniae And Streptococcus Pyogenes. 1.2 Otitis Media Cephalexin Capsules Usp Are Indicated For The Treatment Of Otitis Media Caused By Susceptible Isolates Of Streptococcus Pneumoniae, Haemophilus Influenzae, Staphylococcus Aureus, Streptococcus Pyogenes, And Moraxella Catarrhalis. 1.3 Skin And Skin Structure Infections Cephalexin Capsules Usp Are Indicated For The Treatment Of Skin And Skin Structure Infections Caused By Susceptible Isolates Of The Following Gram-Positive Bacteria: Staphylococcus Aureus And Streptococcus Pyogenes. 1.4 Bone Infections Cephalexin Capsules Usp Are Indicated For The Treatment Of Bone Infections Caused By Susceptible Isolates Of Staphylococcus Aureus And Proteus Mirabilis. 1.5 Genitourinary Tract Infections Cephalexin Capsules Usp Are Indicated For The Treatment Of Genitourinary Tract Infections, Including Acute Prostatitis, Caused By Susceptible Isolates Of Escherichia Coli, Proteus Mirabilis, And Klebsiella Pneumoniae. 1.6 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cephalexin Capsules Usp And Other Antibacterial Drugs, Cephalexin Capsules Usp Should Be Used Only To Treat Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Is Available, This Information 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.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Fd&c Yellow No. 6 FD&C YELLOW NO. 6 Molecular DYE-Dye
2. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
3. Gelatin GELATIN Unresolved
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cephalexin CEPHALEXIN ZINC3830500

Comments