Methotrexate Sodium

NDA 20079, held by Epic Pharma LLC. Calcium Chloride; Dextrose; Glutathione Disulfide; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate.

As of Nov 13, 2026, NDA 20079 (Methotrexate Sodium), held by Epic Pharma LLC, was first approved by FDA on Nov 27, 1991, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 27, 1991
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 27, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methotrexate Sodium0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML · solution;irrigation	Calcium Chloride; Dextrose; Glutathione Disulfide; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate	Discontinued

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 16, 1996	Supplement 2Labeling	Approved	None posted
Apr 16, 1996	Supplement 3Labeling	Approved	None posted
May 12, 1992	Supplement 1Labeling	Approved	None posted
Nov 27, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20079
Drugs@FDA: Overview at FDA
Company: Epic Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters