Last Updated: May 3, 2026

Details for New Drug Application (NDA): 012967

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NDA 012967 describes ORAGRAFIN SODIUM, which is a drug marketed by Bracco and is included in one NDA. Additional details are available on the ORAGRAFIN SODIUM profile page.

The generic ingredient in ORAGRAFIN SODIUM is ipodate sodium. There is one drug master file entry for this compound. Additional details are available on the ipodate sodium profile page.

Summary for 012967

Tradename:	ORAGRAFIN SODIUM
Applicant:	Bracco
Ingredient:	ipodate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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