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Generated: January 19, 2019

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Details for New Drug Application (NDA): 208551

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NDA 208551 describes TRIFERIC , which is a drug marketed by Rockwell Medical Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the TRIFERIC profile page.

The generic ingredient in TRIFERIC is ferric pyrophosphate citrate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ferric pyrophosphate citrate profile page.
Summary for 208551
Applicant:Rockwell Medical Inc
Ingredient:ferric pyrophosphate citrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 208551
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 208551
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIFERIC ferric pyrophosphate citrate FOR SOLUTION;INTRAVENOUS 208551 NDA Rockwell Medical, Inc 57278-315 57278-315-02 100 PACKET in 1 CARTON (57278-315-02) > 1 POWDER in 1 PACKET
TRIFERIC ferric pyrophosphate citrate FOR SOLUTION;INTRAVENOUS 208551 NDA Ropack Inc. 64811-315 64811-315-02 100 PACKET in 1 CARTON (64811-315-02) > 272 mg in 1 PACKET

Profile for product number 001

Approval Date:Apr 25, 2016TE:RLD:Yes

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