Details for New Drug Application (NDA): 020351

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NDA 020351 describes VISIPAQUE 320, which is a drug marketed by Ge Healthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the VISIPAQUE 320 profile page.

The generic ingredient in VISIPAQUE 320 is iodixanol. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iodixanol profile page.

Summary for 020351

Tradename:	VISIPAQUE 320
Applicant:	Ge Healthcare
Ingredient:	iodixanol
Patents:	0

Pharmacology for NDA: 020351

Mechanism of Action	X-Ray Contrast Activity

Suppliers and Packaging for NDA: 020351

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020351	NDA	GE Healthcare Inc.	0407-2222	0407-2222-16	10 BOTTLE, PLASTIC in 1 BOX (0407-2222-16) / 50 mL in 1 BOTTLE, PLASTIC
VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020351	NDA	GE Healthcare Inc.	0407-2222	0407-2222-17	10 BOTTLE, PLASTIC in 1 BOX (0407-2222-17) / 100 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	55%
Approval Date:	Mar 22, 1996	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	65.2%
Approval Date:	Mar 22, 1996	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020351

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	⤷ Subscribe	⤷ Subscribe
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020351-001	Mar 22, 1996	⤷ Subscribe	⤷ Subscribe
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	⤷ Subscribe	⤷ Subscribe
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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