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UVADEX

UVADEX (Methoxsalen) STERILE SOLUTION, 20 mcg/mL

Approved
Approval ID

5ad333bd-845f-43f8-9ecf-43491f26c7c7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 10, 2023

Manufacturers
FDA

Therakos, Inc.

DUNS: 003083703

Products 1

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

Methoxsalen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64067-216
Application NumberNDA020969
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methoxsalen
Product Specifications
Route of AdministrationEXTRACORPOREAL
Effective DateNovember 10, 2023
FDA Product Classification

INGREDIENTS (1)

MethoxsalenActive
Quantity: 20 ug in 1 mL
Code: U4VJ29L7BQ
Classification: ACTIB

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UVADEX - FDA Drug Approval Details