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Details for New Drug Application (NDA): 205874

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NDA 205874 describes AURYXIA, which is a drug marketed by Keryx Biopharms and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the AURYXIA profile page.

The generic ingredient in AURYXIA is ferric citrate. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric citrate profile page.

Summary for NDA: 205874

Tradename:
AURYXIA
Applicant:
Keryx Biopharms
Ingredient:
ferric citrate
Patents:12
Formulation / Manufacturing:see details

Pharmacology for NDA: 205874

Ingredient-typeIron
Mechanism of ActionPhosphate Chelating Activity

Suppliers and Packaging for NDA: 205874

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AURYXIA
ferric citrate
TABLET;ORAL 205874 NDA Keryx Biopharmaceuticals, Inc. 59922-631 59922-631-01 200 TABLET, COATED in 1 BOTTLE (59922-631-01)
AURYXIA
ferric citrate
TABLET;ORAL 205874 NDA Keryx Biopharmaceuticals, Inc. 59922-631 59922-631-91 200 TABLET, COATED in 1 BOTTLE (59922-631-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 210MG IRON
Approval Date:Sep 5, 2014TE:RLD:Yes
Patent:7,767,851Patent Expiration:Feb 18, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:8,299,298Patent Expiration:Feb 18, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,609,896Patent Expiration:Feb 18, 2024Product Flag?YSubstance Flag?Delist Request?


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