Application Nr Approved Date Route Status External Links
ANDA088832 1985-12-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Prednisone Tablets, Usp Are Indicated In The Following Conditions: Endocrine Disorders Primary Or Secondary Adrenocortical Insufficiency (hydrocortisone Or Cortisone Is The First Choice: Synthetic Analogs May Be Used In Conjunction With Mineralocorticoids Where Applicable; In Infancy Mineralocorticoid Supplementation Is Of Particular Importance); Congenital Adrenal Hyperplasia; Hypercalcemia Associated With Cancer; Nonsuppurative Thyroiditis. Rheumatic Disorders As Adjunctive Therapy For Short-Term Administration (to Tide The Patient Over An Acute Episode Or Exacerbation) In: Psoriatic Arthritis, Rheumatoid Arthritis, Including Juvenile Rheumatoid Arthritis (selected Cases May Require Low-Dose Maintenance Therapy), Ankylosing Spondylitis, Acute And Subacute Bursitis, Acute Nonspecific Tenosynovitis, Acute Gouty Arthritis, Post-Traumatic Osteoarthritis, Synovitis Of Osteoarthritis, Epicondylitis. Collagen Diseases During An Exacerbation Or As Maintenance Therapy In Selected Cases Of: Systemic Lupus Erythematosus, Systemic Dermatomyositis (polymyositis), Acute Rheumatic Carditis. Dermatologic Diseases Pemphigus; Bullous Dermatitis Herpetiformis; Severe Erythema Multiforme (stevens-Johnson Syndrome); Exfoliative Dermatitis; Mycosis Fungoides; Severe Psoriasis; Severe Seborrheic Dermatitis. Allergic States Control Of Severe Or Incapacitating Allergic Conditions Intractable To Adequate Trials Of Conventional Treatment: Seasonal Or Perennial Allergic Rhinitis; Bronchial Asthma; Contact Dermatitis; Atopic Dermatitis; Serum Sickness; Drug Hypersensitivity Reactions. Ophthalmic Diseases Severe Acute And Chronic Allergic And Inflammatory Processes Involving The Eye And Its Adnexa Such As: Allergic Corneal Marginal Ulcers, Herpes Zoster Ophthalmicus, Anterior Segment Inflammation, Diffuse Posterior Uveitis And Choroiditis, Sympathetic Ophthalmia, Allergic Conjunctivitis, Keratitis, Chorioretinitis, Optic Neuritis, Iritis And Iridocyclitis. Respiratory Diseases Symptomatic Sarcoidosis; Loeffler’s Syndrome Not Manageable By Other Means; Berylliosis; Fulminating Or Disseminated Pulmonary Tuberculosis When Used Concurrently With Appropriate Antituberculous Chemotherapy; Aspiration Pneumonitis. Hematologic Disorders Idiopathic Thrombocytopenic Purpura In Adults; Secondary Thrombocytopenia In Adults; Acquired (autoimmune) Hemolytic Anemia; Erythroblastopenia (rbc Anemia); Congenital (erythroid) Hypoplastic Anemia. Neoplastic Diseases For Palliative Management Of: Leukemias And Lymphomas In Adults, Acute Leukemia Of Childhood. Edematous States To Induce A Diuresis Or Remission Of Proteinuria In The Nephrotic Syndrome, Without Uremia, Of The Idiopathic Type Or That Due To Lupus Erythematosus. Gastrointestinal Diseases To Tide The Patient Over A Critical Period Of The Disease In: Ulcerative Colitis, Regional Enteritis. Miscellaneous Tuberculous Meningitis With Subarachnoid Block Or Impending Block When Used Concurrently With Appropriate Antituberculous Chemotherapy; Trichinosis With Neurologic Or Myocardial Involvement.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
2. 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.
3. Chloroform CHLOROFORM Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Prednisone PREDNISONE ZINC3875357