Details for New Drug Application (NDA): 021119

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NDA 021119 describes VISUDYNE, which is a drug marketed by Bausch Lomb Ireland 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:	Bausch Lomb Ireland
Ingredient:	verteporfin
Patents:	0

Pharmacology for NDA: 021119

Mechanism of Action	Photoabsorption
Physiological Effect	Photosensitizing 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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	15MG/VIAL
Approval Date:	Apr 12, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021119

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	5,798,349	⤷ Subscribe
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	5,214,036	⤷ Subscribe
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	5,770,619	⤷ Subscribe
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	4,833,790	⤷ Subscribe
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	5,707,608	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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