Application Nr Approved Date Route Status External Links
ANDA204239 2015-12-21 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Linezolid Is Indicated For The Treatment Of Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Specific Conditions Listed Below. Linezolid Is Not Indicated For The Treatment Of Gram-Negative Infections. It Is Critical That Specific Gram-Negative Therapy Be Initiated Immediately If A Concomitant Gram-Negative Pathogen Is Documented Or Suspected [see Warnings And Precautions (5.4)]. Linezolid Is An Oxazolidinone-Class Antibacterial Indicated In Adults For The Treatment Of The Following Infections Caused By Susceptible Gram-Positive Bacteria: Nosocomial Pneumonia (1.1); Community-Acquired Pneumonia (1.1); Complicated Skin And Skin Structure Infections, Including Diabetic Foot Infections, Without Concomitant Osteomyelitis (1.2); Uncomplicated Skin And Skin Structure Infections (1.2); Vancomycin-Resistant Enterococcus Faecium Infections (1.3) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Linezolid Formulations And Other Antibacterial Drugs, Linezolid Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Bacteria.(1.4) 1.1 Pneumonia Nosocomial Pneumonia Caused By Staphylococcus Aureus (methicillin-Susceptible And -Resistant Isolates) Or Streptococcus Pneumoniae [ See Clinical Studies (14 )]. Community-Acquired Pneumonia Caused By Streptococcus Pneumoniae, Including Cases With Concurrent Bacteremia, Or Staphylococcus Aureus (methicillin-Susceptible Isolates Only) [ See Clinical Studies (14) ]. 1.2 Skin And Skin Structure Infections Complicated Skin And Skin Structure Infections, Including Diabetic Foot Infections, Without Concomitant Osteomyelitis, Caused By Staphylococcus Aureus (methicillin-Susceptible And -Resistant Isolates), Streptococcus Pyogenes, Or Streptococcus Agalactiae. Linezolid Has Not Been Studied In The Treatment Of Decubitus Ulcers [see Clinical Studies (14)]. Uncomplicated Skin And Skin Structure Infections Caused By Staphylococcus Aureus (methicillin-Susceptible Isolates Only) Or Streptococcus Pyogenes [ See Clinical Studies (14) ]. 1.3 Vancomycin-Resistant Enterococcus Faecium Infections Vancomycin-Resistant Enterococcus Faecium Infections, Including Cases With Concurrent Bacteremia [ See Clinical Studies (14 )]. 1.4 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Linezolid And Other Antibacterial Drugs, Linezolid 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. The Safety And Efficacy Of Linezolid Given For Longer Than 28 Days Have Not Been Evaluated In Controlled Clinical Trials.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
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. Polacrilin Potassium POLACRILIN POTASSIUM Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Linezolid LINEZOLID ZINC2008866

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