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FDA NDA · NDA019763

IFOSFAMIDE

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA019763
TYPE
NDA
ORIGINAL APPROVAL
1987-08-14
LATEST ACTION
2024-12-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

IFEX/MESNEX KITDiscontinued
IFOSFAMIDE 1GM/VIAL, MESNA 100MG/ML · INJECTABLE · INJECTION
IFEX · ReferencePrescription
IFOSFAMIDE 1GM/VIAL · INJECTABLE · INJECTION
IFEX/MESNEX KITDiscontinued
IFOSFAMIDE 3GM/VIAL, MESNA 100MG/ML · INJECTABLE · INJECTION
IFEX · ReferencePrescription
IFOSFAMIDE 3GM/VIAL · INJECTABLE · INJECTION

Approval history

2024-12-02Labeling · Supplement 21 · standard — Label ↗AP
2018-07-30Labeling · Supplement 20 · standard — Label ↗AP
2014-08-28Labeling · Supplement 19 · standard — Letter ↗AP
2012-03-01Labeling · Supplement 17 · standard — Label ↗AP
2011-03-23Labeling · Supplement 16 · standard — Letter ↗AP
2001-11-21Manufacturing (CMC) · Supplement 14 · priorityAP
2001-09-06Manufacturing (CMC) · Supplement 13 · priorityAP
1996-12-20Manufacturing (CMC) · Supplement 9 · priorityAP
1996-01-23Manufacturing (CMC) · Supplement 8 · priorityAP
1995-08-09Labeling · Supplement 7 · standardAP
1995-06-15Labeling · Supplement 5 · standardAP
1992-11-10Labeling · Supplement 4 · standardAP
1992-11-10Labeling · Supplement 3 · standardAP
1992-01-27Manufacturing (CMC) · Supplement 2 · priorityAP
1990-02-22Manufacturing (CMC) · Supplement 1 · priorityAP
1987-08-14Type 1 - New Molecular Entity · Original · priorityAP
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