MedPath

Photofrin

These highlights do not include all the information needed to use PHOTOFRIN safely and effectively. See full prescribing information for PHOTOFRIN. PHOTOFRIN (porfimer sodium) for injection, for intravenous useInitial U.S. Approval: 1995

Approved
Approval ID

5c4841b4-fbc0-4163-8ee1-cb28629cbfbf

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 15, 2023

Manufacturers
FDA

Pinnacle Biologics, Inc.

DUNS: 833037612

Products 1

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

Porfimer Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76128-155
Application NumberNDA020451
Product Classification
M
Marketing Category
C73594
G
Generic Name
Porfimer Sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 15, 2023
FDA Product Classification

INGREDIENTS (1)

PORFIMER SODIUMActive
Quantity: 75 mg in 31.8 mL
Code: Y3834SIK5F
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Photofrin - FDA Drug Approval Details