APPLICATION
ANDA075874
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-26
LATEST ACTION
2015-05-26
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
IFOSFAMIDE/MESNA KITDiscontinued
IFOSFAMIDE 1GM/20ML, MESNA 1GM/10ML (50MG/ML · INJECTABLE · INTRAVENOUS
IFOSFAMIDE/MESNA KITDiscontinued
IFOSFAMIDE 3GM/60ML, MESNA 1GM/10ML (50MG/ML · INJECTABLE · INTRAVENOUS
Approval history
2015-05-26Labeling · Supplement 33 · standardAP
2015-05-26Labeling · Supplement 30 · standardAP
2015-05-26Labeling · Supplement 37 · standardAP
2011-03-21Labeling · Supplement 17AP
2003-01-17Labeling · Supplement 6AP
2002-12-13Manufacturing (CMC) · Supplement 1AP
2002-02-26OriginalAP
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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