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Triferic AVNU

These highlights do not include all the information needed to use TRIFERIC AVNU safely and effectively. See full prescribing information for TRIFERIC AVNU. TRIFERIC AVNU (ferric pyrophosphate citrate injection), for intravenous use Initial U.S. Approval: 2015

Approved
Approval ID

51197a48-6078-42cd-b5ed-5ea22b6757b4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 15, 2020

Manufacturers
FDA

Rockwell Medical Inc.

DUNS: 933721433

Products 1

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

ferric pyrophosphate citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57278-318
Application NumberNDA212860
Product Classification
M
Marketing Category
C73594
G
Generic Name
ferric pyrophosphate citrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 15, 2020
FDA Product Classification

INGREDIENTS (1)

FERRIC PYROPHOSPHATE CITRATEActive
Quantity: 1.5 mg in 1 mL
Code: UBY79OCO9G
Classification: ACTIM

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Triferic AVNU - FDA Drug Approval Details