Details for New Drug Application (NDA): 020808

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NDA 020808 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 020808

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

Pharmacology for NDA: 020808

Mechanism of Action	X-Ray Contrast Activity

Suppliers and Packaging for NDA: 020808

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808	NDA	GE Healthcare Inc.	0407-2223	0407-2223-23	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-23) / 500 mL in 1 BOTTLE, PLASTIC
VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808	NDA	GE Healthcare Inc.	0407-2223	0407-2223-16	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-16) / 50 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	55%
Approval Date:	Aug 29, 1997	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	65.2%
Approval Date:	Aug 29, 1997	TE:		RLD:	No

Expired US Patents for NDA 020808

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	4,396,597	⤷ Subscribe
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997	4,278,654	⤷ Subscribe
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	4,278,654	⤷ Subscribe
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	5,349,085	⤷ Subscribe
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997	RE36418	⤷ Subscribe
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	RE36418	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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