FDA NDA · NDA206317

TRIFERIC

Sponsor: ROCKWELL MEDICAL INC

APPLICATION

NDA206317

TYPE

NDA

ORIGINAL APPROVAL

2015-01-23

LATEST ACTION

2019-07-10

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

TRIFERIC · ReferenceDiscontinued

FERRIC PYROPHOSPHATE CITRATE 27.2MG IRON/5ML (5.44MG IRON/ML) · SOLUTION · INTRAVENOUS

TRIFERIC · ReferenceDiscontinued

FERRIC PYROPHOSPHATE CITRATE 272MG IRON/50ML (5.44MG IRON/ML) · SOLUTION · INTRAVENOUS

2019-07-10Labeling · Supplement 12 · standard — Letter ↗AP

2018-03-29Labeling · Supplement 10 · standard — Label ↗AP

2017-10-16Labeling · Supplement 9 · standard — Label ↗AP

2016-07-28Manufacturing (CMC) · Supplement 7 · standardAP

2016-05-16Manufacturing (CMC) · Supplement 3 · standardAP

2015-11-12Manufacturing (CMC) · Supplement 4 · standardAP

2015-09-10Manufacturing (CMC) · Supplement 2 · standardAP

2015-01-23Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP

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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