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STERANE (nda009996)- (5MG)

PREDNISOLONE PFIZER
5MG
No No
Expired Expired
None None
None No
STERANE is indicated for: 1. Endocrine disorders *Congenital adrenal hyperplasia *Nonsuppurative thyroiditis *Hypercalcemia associated with cancer 2. Rheumatic disorders *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 3. Collagen diseases *Systemic lupus erythematosus *Acute rheumatic carditis *Systemic dermatomyositis (polymyositis) 4. Dermatologic diseases *Pemphigus *Bullous dermatitis herpetiformis *Severe erythema multiforme (Stevens-Johnson syndrome) *Exfoliative dermatitis *Mycosis fungoides *Severe psoriasis *Severe seborrheic dermatitis 5. Allergic states *Seasonal or perennial allergic rhinitis *Serum sickness *Bronchial asthma *Contact dermatitis *Atopic dermatitis *Drug hypersensitivity reactions 6. Ophthalmic diseases *Allergic conjunctivitis *Keratitis *Allergic corneal marginal ulcers *Herpes zoster ophthalmicus *Iritis and iridocyclitis *Chorioretinitis *Anterior segment inflammation *Diffuse posterior uveitis and choroiditis *Optic neuritis *Sympathetic ophthalmia 7. 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 8. Hematologic disorders *Idiopathic thrombocytopenic purpura in adults *Secondary thrombocytopenia in adults *Acquired (autoimmune) hemolytic anemia *Erythroblastopenia (RBC anemia) *Congenital (erythroid) hypoplastic anemia 9. Neoplastic diseases *Leukemias and lymphomas in adults *Acute leukemia of childhood 10. Edematous states 11. Gastrointestinal diseases *Ulcerative colitis *Regional enteritis 12. Nervous system *Acute exacerbations of multiple sclerosis 13. Miscellaneous *Tuberculous meningitis with sub-arachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.
0 0 0
Total Other Developers None
Drugs with Suitability No
5MG ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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