Application Nr Approved Date Route Status External Links
NDA050715 1995-07-14 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Kidney, Liver, And Heart Transplantation Neoral Is Indicated For The Prophylaxis Of Organ Rejection In Kidney, Liver, And Heart Allogeneic Transplants. Neoral Has Been Used In Combination With Azathioprine And Corticosteroids. Rheumatoid Arthritis Neoral Is Indicated For The Treatment Of Patients With Severe Active, Rheumatoid Arthritis Where The Disease Has Not Adequately Responded To Methotrexate. Neoral Can Be Used In Combination With Methotrexate In Rheumatoid Arthritis Patients Who Do Not Respond Adequately To Methotrexate Alone. Psoriasis Neoral Is Indicated For The Treatment Of Adult, Nonimmunocompromised Patients With Severe (i.e., Extensive And/or Disabling), Recalcitrant, Plaque Psoriasis Who Have Failed To Respond To At Least One Systemic Therapy (e.g., Puva, Retinoids, Or Methotrexate) Or In Patients For Whom Other Systemic Therapies Are Contraindicated, Or Cannot Be Tolerated. While Rebound Rarely Occurs, Most Patients Will Experience Relapse With Neoral As With Other Therapies Upon Cessation Of Treatment.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
3. Carmine CARMINE Molecular DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cyclosporine