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FDA NDA · NDA208551

TRIFERIC

Sponsor: ROCKWELL MEDICAL INC

APPLICATION
NDA208551
TYPE
NDA
ORIGINAL APPROVAL
2016-04-25
LATEST ACTION
2018-03-29
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

TRIFERIC · ReferenceDiscontinued
FERRIC PYROPHOSPHATE CITRATE 272MG IRON/PACKET · POWDER · INTRAVENOUS

Approval history

2018-03-29Labeling · Supplement 5 · standard — Label ↗AP
2017-10-16Labeling · Supplement 3 · standard — Label ↗AP
2016-04-25Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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