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Generated: May 25, 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 two NDAs. It is available from two suppliers. There are two patents protecting this drug. 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
Tradename:TRIFERIC
Applicant:Rockwell Medical Inc
Ingredient:ferric pyrophosphate citrate
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208551
Generic Entry Date for 208551*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;INTRAVENOUSStrength272MG IRON/PACKET
Approval Date:Apr 25, 2016TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 17, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
Patent:➤ Try a Free TrialPatent Expiration:Sep 8, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT

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