Last Updated: May 10, 2026

Details for New Drug Application (NDA): 016847

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NDA 016847 describes ISOPAQUE 440, which is a drug marketed by Ge Healthcare and is included in one NDA. Additional details are available on the ISOPAQUE 440 profile page.

The generic ingredient in ISOPAQUE 440 is calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium profile page.

Summary for 016847

Tradename:	ISOPAQUE 440
Applicant:	Ge Healthcare
Ingredient:	calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Expired US Patents for NDA 016847

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	ISOPAQUE 440	calcium metrizoate; meglumine metrizoate; metrizoate magnesium; metrizoate sodium	INJECTABLE;INJECTION	016847-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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