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FDA NDA · NDA020326

NEUTREXIN

Sponsor: MEDIMMUNE ONCOLOGY

APPLICATION
NDA020326
TYPE
NDA
ORIGINAL APPROVAL
1993-12-17
LATEST ACTION
2005-11-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

NEUTREXINDiscontinued
TRIMETREXATE GLUCURONATE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION
NEUTREXINDiscontinued
TRIMETREXATE GLUCURONATE EQ 25MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2005-11-09Labeling · Supplement 15 · standard — Label ↗AP
2002-06-26Labeling · Supplement 13 · standard — Letter ↗AP
2002-06-26Labeling · Supplement 11 · standard — Label ↗AP
1998-07-31Manufacturing (CMC) · Supplement 10AP
1997-08-28Manufacturing (CMC) · Supplement 8AP
1997-08-05Labeling · Supplement 9 · standardAP
1997-08-05Labeling · Supplement 7 · standardAP
1997-01-21Manufacturing (CMC) · Supplement 6AP
1996-05-13Manufacturing (CMC) · Supplement 5AP
1995-05-09Manufacturing (CMC) · Supplement 4AP
1995-05-09Manufacturing (CMC) · Supplement 2AP
1995-05-09Manufacturing (CMC) · Supplement 3AP
1994-03-04Manufacturing (CMC) · Supplement 1AP
1993-12-17Type 1 - New Molecular Entity · Original · priorityAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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