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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 012968

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NDA 012968 describes ORAGRAFIN CALCIUM, which is a drug marketed by Bracco and is included in one NDA. Additional details are available on the ORAGRAFIN CALCIUM profile page.

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

Summary for 012968

Tradename:	ORAGRAFIN CALCIUM
Applicant:	Bracco
Ingredient:	ipodate calcium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GRANULE;ORAL			Strength	3GM/PACKET
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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