APPLICATION
NDA040024
TYPE
NDA
ORIGINAL APPROVAL
1996-02-23
LATEST ACTION
2016-11-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXFERRUMDiscontinued
IRON DEXTRAN EQ 50MG IRON/ML · INJECTABLE · INJECTION
Approval history
2016-11-18Manufacturing (CMC) · Supplement 25 · standardAP
2002-02-08Labeling · Supplement 12 · standardAP
2001-05-31Manufacturing (CMC) · Supplement 11AP
2000-07-20Manufacturing (CMC) · Supplement 9AP
2000-07-20Manufacturing (CMC) · Supplement 8AP
2000-02-18Labeling · Supplement 10 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 4AP
1998-09-25Labeling · Supplement 7 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 5AP
1998-09-25Manufacturing (CMC) · Supplement 6AP
1998-01-29Labeling · Supplement 2 · standardAP
1998-01-29Labeling · Supplement 3 · standardAP
1996-09-19Manufacturing (CMC) · Supplement 1AP
1996-02-23UNKNOWN · Original · unknownAP
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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