APPLICATION
NDA016267
TYPE
NDA
ORIGINAL APPROVAL
1968-04-01
LATEST ACTION
2022-09-09
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
DESFERAL · ReferenceDiscontinued
DEFEROXAMINE MESYLATE 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DESFERAL · ReferencePrescription
DEFEROXAMINE MESYLATE 500MG/VIAL · INJECTABLE · INJECTION
Approval history
2016-04-27Manufacturing (CMC) · Supplement 52 · priorityAP
2013-06-14Manufacturing (CMC) · Supplement 51 · priorityAP
2002-04-24Manufacturing (CMC) · Supplement 37 · priorityAP
2002-01-15Manufacturing (CMC) · Supplement 40 · priorityAP
2001-07-05Manufacturing (CMC) · Supplement 38 · priorityAP
2001-01-05Manufacturing (CMC) · Supplement 36 · priorityAP
2000-05-25Manufacturing (CMC) · Supplement 33 · priorityAP
2000-04-28Manufacturing (CMC) · Supplement 35 · priorityAP
1998-12-22Manufacturing (CMC) · Supplement 30 · priorityAP
1998-12-22Manufacturing (CMC) · Supplement 29 · priorityAP
1998-12-22Manufacturing (CMC) · Supplement 31 · priorityAP
1998-10-23Manufacturing (CMC) · Supplement 32 · priorityAP
1998-01-30Manufacturing (CMC) · Supplement 24 · priorityAP
1998-01-30Manufacturing (CMC) · Supplement 25 · priorityAP
1997-04-02Labeling · Supplement 28 · standardAP
1995-06-19Labeling · Supplement 27 · standardAP
1994-08-31Labeling · Supplement 26 · standardAP
1990-02-12Manufacturing (CMC) · Supplement 22 · priorityAP
1987-09-08Labeling · Supplement 21AP
1987-02-13Labeling · Supplement 20AP
1986-04-17Labeling · Supplement 15AP
1986-01-08Manufacturing (CMC) · Supplement 18 · priorityAP
1985-09-27Manufacturing (CMC) · Supplement 19 · priorityAP
1984-04-06Manufacturing (CMC) · Supplement 16 · priorityAP
1984-01-04Manufacturing (CMC) · Supplement 17 · priorityAP
1980-09-02Manufacturing (CMC) · Supplement 14 · priorityAP
1980-07-08Manufacturing (CMC) · Supplement 13 · priorityAP
1979-06-04Labeling · Supplement 12AP
1979-06-04Efficacy · Supplement 11AP
1978-04-06Manufacturing (CMC) · Supplement 10 · priorityAP
1978-01-25Manufacturing (CMC) · Supplement 9 · priorityAP
1977-03-04REMS · Supplement 8 · priorityAP
1976-01-20Labeling · Supplement 7AP
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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