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FDA ANDA · ANDA078718

DEFEROXAMINE

deferoxamine mesylate

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA078718
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-15
LATEST ACTION
2023-11-28
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

2023-11-28Labeling · Supplement 9 · standardAP
2012-07-18Labeling · Supplement 6 · standardAP
2012-06-20Labeling · Supplement 5 · standardAP
2011-05-27Labeling · Supplement 3AP
2009-09-15OriginalAP
VIEW ON DRUGS@FDA ↗

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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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