NDA 20326, held by Medimmune Oncology. Trimetrexate Glucuronate.
As of Nov 14, 2026, NDA 20326 (Neutrexin), held by Medimmune Oncology, was first approved by FDA on Dec 17, 1993, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 1993 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| NeutrexinEQ 25MG BASE/VIAL · injectable;injection | Trimetrexate Glucuronate | Discontinued |
| NeutrexinEQ 200MG BASE/VIAL · injectable;injection | Trimetrexate Glucuronate | Discontinued |
| Nov 9, 2005 | Supplement 15Labeling · Standard review | Approved | |
| Jun 26, 2002 | Supplement 13Labeling · Standard review | Approved | |
| Jun 26, 2002 | Supplement 11Labeling · Standard review | Approved | |
| Jul 31, 1998 | Supplement 10Manufacturing | Approved | None posted |
| Aug 28, 1997 | Supplement 8Manufacturing | Approved | None posted |
| Aug 5, 1997 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 5, 1997 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 21, 1997 | Supplement 6Manufacturing | Approved | None posted |
| May 13, 1996 | Supplement 5Manufacturing | Approved | None posted |
| May 9, 1995 | Supplement 4Manufacturing | Approved | None posted |
| May 9, 1995 | Supplement 3Manufacturing | Approved | None posted |
| May 9, 1995 | Supplement 2Manufacturing | Approved | None posted |
| Mar 4, 1994 | Supplement 1Manufacturing | Approved | None posted |
| Dec 17, 1993 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
