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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021119


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NDA 021119 describes VISUDYNE, which is a drug marketed by Valeant Luxembourg and is included in one NDA. It is available from two suppliers. Additional details are available on the VISUDYNE profile page.

The generic ingredient in VISUDYNE is verteporfin. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the verteporfin profile page.
Summary for 021119
Tradename:VISUDYNE
Applicant:Valeant Luxembourg
Ingredient:verteporfin
Patents:0
Pharmacology for NDA: 021119
Mechanism of ActionPhotoabsorption
Physiological EffectPhotosensitizing Activity
Suppliers and Packaging for NDA: 021119
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VISUDYNE verteporfin INJECTABLE;INJECTION 021119 NDA Bausch Health US LLC 0187-5600 0187-5600-15 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0187-5600-15)
VISUDYNE verteporfin INJECTABLE;INJECTION 021119 NDA Bausch & Lomb Incorporated 24208-560 24208-560-15 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (24208-560-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/VIAL
Approval Date:Apr 12, 2000TE:RLD:Yes

Expired US Patents for NDA 021119

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Luxembourg VISUDYNE verteporfin INJECTABLE;INJECTION 021119-001 Apr 12, 2000 ⤷  Try a Trial ⤷  Try a Trial
Valeant Luxembourg VISUDYNE verteporfin INJECTABLE;INJECTION 021119-001 Apr 12, 2000 ⤷  Try a Trial ⤷  Try a Trial
Valeant Luxembourg VISUDYNE verteporfin INJECTABLE;INJECTION 021119-001 Apr 12, 2000 ⤷  Try a Trial ⤷  Try a Trial
Valeant Luxembourg VISUDYNE verteporfin INJECTABLE;INJECTION 021119-001 Apr 12, 2000 ⤷  Try a Trial ⤷  Try a Trial
Valeant Luxembourg VISUDYNE verteporfin INJECTABLE;INJECTION 021119-001 Apr 12, 2000 ⤷  Try a Trial ⤷  Try a Trial
Valeant Luxembourg VISUDYNE verteporfin INJECTABLE;INJECTION 021119-001 Apr 12, 2000 ⤷  Try a Trial ⤷  Try a Trial
Valeant Luxembourg VISUDYNE verteporfin INJECTABLE;INJECTION 021119-001 Apr 12, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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