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Auryxia

These highlights do not include all the information needed to use AURYXIA safely and effectively. See full prescribing information for AURYXIA. AURYXIA (ferric citrate) tablets, for oral use Initial U.S. Approval: 2014

Approved
Approval ID

aadd18e0-3752-11e4-8510-0800200c9a66

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 22, 2024

Manufacturers
FDA

Akebia Therapeutics, Inc.

DUNS: 809557593

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ferric citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59922-631
Application NumberNDA205874
Product Classification
M
Marketing Category
C73594
G
Generic Name
ferric citrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2021
FDA Product Classification

INGREDIENTS (1)

TETRAFERRIC TRICITRATE DECAHYDRATEActive
Quantity: 210 mg in 1 1
Code: Q91187K011
Classification: ACTIM

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Auryxia - FDA Drug Approval Details