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FDA NDA · NDA021626

RADIOGARDASE

prussian blue insoluble capsules

Sponsor: HEYL CHEMISCH

APPLICATION
NDA021626
TYPE
NDA
ORIGINAL APPROVAL
2003-10-02
LATEST ACTION
2014-08-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

RADIOGARDASE (PRUSSIAN BLUE) · ReferencePrescription
FERRIC HEXACYANOFERRATE(II) 500MG · CAPSULE · ORAL

Approval history

2014-08-20Labeling · Supplement 10 · standard — Label ↗AP
2008-09-12Manufacturing (CMC) · Supplement 8 · priorityAP
2008-08-25Manufacturing (CMC) · Supplement 7 — Label ↗AP
2008-02-15Manufacturing (CMC) · Supplement 6 · priorityAP
2006-11-20Manufacturing (CMC) · Supplement 5 · priorityAP
2005-09-12Manufacturing (CMC) · Supplement 4 · priorityAP
2005-06-30Manufacturing (CMC) · Supplement 3 · priorityAP
2004-09-24Manufacturing (CMC) · Supplement 2 · priorityAP
2004-05-11Manufacturing (CMC) · Supplement 1 · priority — Letter ↗AP
2003-10-02Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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