Drug application

METHOTREXATE SODIUM (CALCIUM CHLORIDE, DEXTROSE, GLUTATHIONE DISULFIDE and 5 more)

Drugs@FDA NDA 020079 · EPIC PHARMA LLC

Key facts

Drug name METHOTREXATE SODIUM
Active ingredients CALCIUM CHLORIDE, DEXTROSE, GLUTATHIONE DISULFIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM PHOSPHATE
Application type NDA
Application number 020079
Company EPIC PHARMA LLC
Dosage forms 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
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 3 - New Dosage Form
Latest submission status date Nov 27, 1991

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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