APPLICATION
ANDA076019
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-17
LATEST ACTION
2025-05-08
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEFEROXAMINE MESYLATEPrescription
DEFEROXAMINE MESYLATE 2GM/VIAL · INJECTABLE · INJECTION
DEFEROXAMINE MESYLATEPrescription
DEFEROXAMINE MESYLATE 500MG/VIAL · INJECTABLE · INJECTION
Approval history
2025-05-08Labeling · Supplement 30 · standardAP
2023-10-23Labeling · Supplement 20 · standardAP
2023-10-23Labeling · Supplement 27 · standardAP
2016-11-08Labeling · Supplement 14 · standardAP
2009-12-03Labeling · Supplement 11AP
2007-12-14Labeling · Supplement 8AP
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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