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FDA Approval

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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

Products2

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

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Product Details

NDC Product Code
57278-315
Application Number
NDA208551
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
September 15, 2020
Code: UBY79OCO9GClass: ACTIMQuantity: 272 mg in 1 1

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Product Details

NDC Product Code
57278-314
Application Number
NDA206317
Marketing Category
NDA (C73594)
Route of Administration
HEMODIALYSIS
Effective Date
September 15, 2020
Code: UBY79OCO9GClass: ACTIMQuantity: 5.44 mg in 1 mL
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