← FDA DRUG APPROVALS

FDA NDA · NDA020221

ETHYOL

amifostine

Sponsor: LEGACY

APPLICATION
NDA020221
TYPE
NDA
ORIGINAL APPROVAL
1995-12-08
LATEST ACTION
2019-07-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

ETHYOL · ReferencePrescription
AMIFOSTINE 500MG/VIAL · INJECTABLE · INJECTION
ETHYOLDiscontinued
AMIFOSTINE 375MG/VIAL · INJECTABLE · INJECTION

Approval history

2019-07-25Labeling · Supplement 36 · standard — Letter ↗AP
2017-05-25Labeling · Supplement 33 · standard — Label ↗AP
2016-12-15Labeling · Supplement 32 · standard — Label ↗AP
2016-03-09Manufacturing (CMC) · Supplement 30 · priorityAP
2016-01-15Manufacturing (CMC) · Supplement 31 · priorityAP
2013-08-26Manufacturing (CMC) · Supplement 28 · priorityAP
2008-11-07Labeling · Supplement 24 · standard — Label ↗AP
2006-03-28Labeling · Supplement 20 · standard — Letter ↗AP
2003-03-27Labeling · Supplement 17 · standard — Letter ↗AP
2002-02-20Labeling · Supplement 15 · standard — Letter ↗AP
1999-09-10Manufacturing (CMC) · Supplement 14 · priorityAP
1999-06-24Efficacy · Supplement 12 · priority — Review ↗AP
1999-04-01Labeling · Supplement 13 · standardAP
1999-03-11Labeling · Supplement 10 · standardAP
1999-02-11Manufacturing (CMC) · Supplement 11 · priorityAP
1997-10-10Manufacturing (CMC) · Supplement 9 · priorityAP
1997-02-20Manufacturing (CMC) · Supplement 7 · priorityAP
1996-12-30Manufacturing (CMC) · Supplement 3 · priorityAP
1996-12-18Manufacturing (CMC) · Supplement 5 · priorityAP
1996-11-21Manufacturing (CMC) · Supplement 4 · priorityAP
1996-03-15Efficacy · Supplement 2 · unknownAP
1996-01-23Manufacturing (CMC) · Supplement 1 · priorityAP
1995-12-08Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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