Orange Book product · Brand (NDA)

TRIFERIC

FERRIC PYROPHOSPHATE CITRATE

Brand (NDA)NDA 208551DISCN ROCKWELL MEDICAL INC

Apr 25, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 25, 2016
10 yr 4 mo ago
Today
Patent 7857977 expires
Listed method-of-use patent (U-1656) expiration.
Sep 08, 2027
in 1 yr 3 mo
Patent 7816404 expires
Listed method-of-use patent (U-1656) expiration.
Apr 17, 2029
in 2 yr 10 mo

Active ingredient

FERRIC PYROPHOSPHATE CITRATE

Strength

272MG IRON/PACKET

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 208551

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
7857977	Sep 08, 2027	in 1 yr 3 mo	U-1656
7816404	Apr 17, 2029	in 2 yr 10 mo	U-1656