Details for New Drug Application (NDA): 018956

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NDA 018956 describes OMNIPAQUE 70, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the OMNIPAQUE 70 profile page.

The generic ingredient in OMNIPAQUE 70 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 018956

Tradename:	OMNIPAQUE 70
Applicant:	Ge Healthcare
Ingredient:	iohexol
Patents:	0

Pharmacology for NDA: 018956

Mechanism of Action	X-Ray Contrast Activity

Medical Subject Heading (MeSH) Categories for 018956

Contrast Media

Suppliers and Packaging for NDA: 018956

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956	NDA	GE Healthcare Inc.	0407-1401	0407-1401-52	10 BOTTLE, PLASTIC in 1 BOX (0407-1401-52) / 50 mL in 1 BOTTLE, PLASTIC
OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956	NDA	GE Healthcare Inc.	0407-1411	0407-1411-10	10 VIAL, GLASS in 1 BOX (0407-1411-10) / 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION, ORAL, RECTAL			Strength	38.8%
Approval Date:	Dec 26, 1985	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION, ORAL, RECTAL			Strength	51.8%
Approval Date:	Dec 26, 1985	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION, ORAL, RECTAL			Strength	64.7%
Approval Date:	Dec 26, 1985	TE:		RLD:	Yes

Expired US Patents for NDA 018956

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985	4,021,481	⤷ Subscribe
Ge Healthcare	OMNIPAQUE 70	iohexol	SOLUTION;URETHRAL	018956-007	Jun 1, 1994	4,396,597	⤷ Subscribe
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985	4,250,113	⤷ Subscribe
Ge Healthcare	OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	018956-004	Dec 26, 1985	4,250,113	⤷ Subscribe
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