Details for New Drug Application (NDA): 020608

NDA 020608 describes OMNIPAQUE 300, which is a drug marketed by Ge Healthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the OMNIPAQUE 300 profile page.

The generic ingredient in OMNIPAQUE 300 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.

Summary for 020608

Tradename:	OMNIPAQUE 300
Applicant:	Ge Healthcare
Ingredient:	iohexol
Patents:	0

Pharmacology for NDA: 020608

Mechanism of Action

X-Ray Contrast Activity

Medical Subject Heading (MeSH) Categories for 020608

Contrast Media

Suppliers and Packaging for NDA: 020608

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	020608	NDA	GE Healthcare Inc.	0407-1413	0407-1413-10	10 VIAL, GLASS in 1 BOX (0407-1413-10) / 10 mL in 1 VIAL, GLASS
OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	020608	NDA	GE Healthcare Inc.	0407-1413	0407-1413-53	10 BOTTLE, GLASS in 1 BOX (0407-1413-53) / 125 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INJECTION, ORAL, RECTAL			Strength	51.8%
Approval Date:	Oct 24, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION, ORAL, RECTAL			Strength	64.7%
Approval Date:	Oct 24, 1995	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION, ORAL			Strength	75.5%
Approval Date:	Oct 24, 1995	TE:		RLD:	No

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