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FDA Approval

Triferic AVNU

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Rockwell Medical Inc.
DUNS: 933721433
Effective Date
September 15, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Products1

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

Triferic AVNU

Product Details

NDC Product Code
57278-318
Application Number
NDA212860
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
September 15, 2020
Code: UBY79OCO9GClass: ACTIMQuantity: 1.5 mg in 1 mL
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