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FDA NDA · NDA020955

FERRLECIT

sodium ferric gluconate complex

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA020955
TYPE
NDA
ORIGINAL APPROVAL
1999-02-18
LATEST ACTION
2022-03-16
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FERRLECIT · ReferencePrescription
SODIUM FERRIC GLUCONATE COMPLEX EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) · INJECTABLE · INJECTION

Approval history

2022-03-16Labeling · Supplement 20 · standard — Label ↗AP
2020-12-02Labeling · Supplement 19 · standard — Letter ↗AP
2020-03-31Labeling · Supplement 17 · standard — Label ↗AP
2013-02-01Manufacturing (CMC) · Supplement 16 · priorityAP
2011-08-25Labeling · Supplement 15 · unknown — Letter ↗AP
2011-08-25Labeling · Supplement 13 · unknown — Letter ↗AP
2006-10-02Labeling · Supplement 10 · standard — Label ↗AP
2004-08-13Efficacy · Supplement 6 · priority — Label ↗AP
2002-06-07Labeling · Supplement 5 · standard — Letter ↗AP
2002-04-09Manufacturing (CMC) · Supplement 4 · priorityAP
2001-02-02Efficacy · Supplement 3 · priority — Review ↗AP
1999-07-27Manufacturing (CMC) · Supplement 1 · priority — Review ↗AP
1999-02-18Type 1 - New Molecular Entity · Original · priority — Review ↗AP
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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