Orange Book product · Brand (NDA)

TRIFERIC

FERRIC PYROPHOSPHATE CITRATE

Brand (NDA)NDA 206317DISCN ROCKWELL MEDICAL INC

Jan 23, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 23, 2015
11 yr 7 mo ago
Today
Patent 7816404 expires
Listed drug product patent expiration.
Apr 17, 2029
in 2 yr 10 mo

Active ingredient

FERRIC PYROPHOSPHATE CITRATE

Strength

27.2MG IRON/5ML (5.44MG IRON/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 206317

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7816404	Apr 17, 2029	in 2 yr 10 mo	ProductU-1656