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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020079

METHOTREXATE SODIUM (CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE)
0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML
Marketing Status: Discontinued
Active Ingredient: CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
Proprietary Name: METHOTREXATE SODIUM
Dosage Form; Route of Administration: SOLUTION; IRRIGATION
Strength: 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020079
Product Number: 001
Approval Date: Feb 26, 1999
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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