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FDA Approval

Photofrin

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

FDA Approval Summary

Company
Effective Date
August 15, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Porfimer Sodium(75 mg in 31.8 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Jubilant HollisterStier

Pinnacle Biologics, Inc.

246762764

Products1

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

Photofrin

Product Details

NDC Product Code
76128-155
Application Number
NDA020451
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
August 15, 2023
Code: Y3834SIK5FClass: ACTIBQuantity: 75 mg in 31.8 mL
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