Bsp 0820

Product manufactured by Oaklock, Llc

Application Nr Approved Date Route Status External Links
ANDA090747 None Intra-Articular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage When Oral Therapy Is Not Feasible, The Intramuscular Use Of Betamethasone Sodium Phosphate And Betamethasone Acetate Injectable Suspension Is Indicated As Follows: Allergic States Control Of Severe Or Incapacitating Allergic Conditions Intractable To Adequate Trials Of Conventional Treatment In Asthma, Atopic Dermatitis, Contact Dermatitis, Drug Hypersensitivity Reactions, Perennial Or Seasonal Allergic Rhinitis, Serum Sickness, Transfusion Reactions. Dermatologic Diseases Bullous Dermatitis Herpetiformis, Exfoliative Erythroderma, Mycosis Fungoides, Pemphigus, Severe Erythema Multiforme (Stevens-Johnson Syndrome). Endocrine Disorders Congenital Adrenal Hyperplasia, Hypercalcemia Associated With Cancer, Nonsuppurative Thyroiditis. Hydrocortisone Or Cortisone Is The Drug Of Choice In Primary Or Secondary Adrenocortical Insufficiency. Synthetic Analogs May Be Used In Conjunction With Mineralocorticoids Where Applicable; In Infancy Mineralocorticoid Supplementation Is Of Particular Importance. Gastrointestinal Diseases To Tide The Patient Over A Critical Period Of The Disease In Regional Enteritis And Ulcerative Colitis. Hematologic Disorders Acquired (Autoimmune) Hemolytic Anemia, Diamond-Blackfan Anemia, Pure Red Cell Aplasia, Selected Cases Of Secondary Thrombocytopenia. Miscellaneous Trichinosis With Neurologic Or Myocardial Involvement, Tuberculous Meningitis With Subarachnoid Block Or Impending Block When Used With Appropriate Antituberculous Chemotherapy. Neoplastic Diseases For Palliative Management Of Leukemias And Lymphomas. Nervous System Acute Exacerbations Of Multiple Sclerosis; Cerebral Edema Associated With Primary Or Metastatic Brain Tumor Or Craniotomy. Ophthalmic Diseases Sympathetic Ophthalmia, Temporal Arteritis, Uveitis And Ocular Inflammatory Conditions Unresponsive To Topical Corticosteroids. Renal Diseases To Induce Diuresis Or Remission Of Proteinuria In Idiopathic Nephrotic Syndrome Or That Due To Lupus Erythematosus. Respiratory Diseases Berylliosis, Fulminating Or Disseminated Pulmonary Tuberculosis When Used Concurrently With Appropriate Antituberculous Chemotherapy, Idiopathic Eosinophilic Pneumonias, Symptomatic Sarcoidosis. Rheumatic Disorders As Adjunctive Therapy For Short-Term Administration (To Tide The Patient Over An Acute Episode Or Exacerbation) In Acute Gouty Arthritis; Acute Rheumatic Carditis; Ankylosing Spondylitis; Psoriatic Arthritis; Rheumatoid Arthritis, Including Juvenile Rheumatoid Arthritis (Selected Cases May Require Low-Dose Maintenance Therapy). For The Treatment Of Dermatomyositis, Polymyositis, And Systemic Lupus Erythematosus. The Intra-Articular Or Soft Tissue Administration Of Betamethasone Sodium Phosphate And Betamethasone Acetate Injectable Suspension Is Indicated As Adjunctive Therapy For Short-Term Administration (To Tide The Patient Over An Acute Episode Or Exacerbation) In Acute Gouty Arthritis, Acute And Subacute Bursitis, Acute Nonspecific Tenosynovitis, Epicondylitis, Rheumatoid Arthritis, Synovitis Of Osteoarthritis. The Intralesional Administration Of Betamethasone Sodium Phosphate And Betamethasone Acetate Injectable Suspension Is Indicated For Alopecia Areata; Discoid Lupus Erythematosus; Keloids; Localized Hypertrophic, Infiltrated, Inflammatory Lesions Of Granuloma Annulare, Lichen Planus, Lichen Simplex Chronicus (Neurodermatitis), And Psoriatic Plaques; Necrobiosis Lipoidica Diabeticorum. Betamethasone Sodium Phosphate And Betamethasone Acetate Injectable Suspension May Also Be Useful In Cystic Tumors Of An Aponeurosis Or Tendon (Ganglia).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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