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SOLU-MEDROL (nda011856)- (EQ 40MG BASE/VIAL,EQ 125MG BASE/VIAL,EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL,EQ 2GM BASE/VIAL)

METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACIA AND UPJOHN
EQ 40MG BASE/VIAL,EQ 125MG BASE/VIAL,EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL,EQ 2GM BASE/VIAL
No No
Expired Expired
None None
None No
SOLU-MEDROL Sterile Powder 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, serum sickness, transfusion reactions. *Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). *Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of 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. *Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. *Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenicpurpura in adults (intravenous administration only; intramuscular administration is contraindicated), 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 concurrently with appropriate antituberculous chemotherapy. *Neoplastic diseases: For the 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, 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, temporal arteritis, polymyositis, and systemic lupus erythematosus.
8 0 7
Total Other Developers 8
Drugs with Suitability No
EQ 40MG BASE/VIAL ** ** - - -
EQ 125MG BASE/VIAL ** ** - - -
EQ 500MG BASE/VIAL ** ** - - -
EQ 1GM BASE/VIAL ** ** - - -
EQ 2GM BASE/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 6
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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