Oragrafin Calcium

NDA 12968, held by Bracco. Ipodate Calcium.

As of Nov 14, 2026, NDA 12968 (Oragrafin Calcium), held by Bracco, was first approved by FDA on Mar 15, 1962, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 15, 1962
Review: Priority
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 15, 1962	Original applicationNew active ingredient · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oragrafin Calcium3GM/PACKET · granule;oral	Ipodate Calcium	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 6, 1991	Supplement 12Manufacturing · Priority review	Approved	None posted
Sep 13, 1979	Supplement 10Labeling · Priority review	Approved	None posted
Jun 8, 1978	Supplement 8Labeling · Priority review	Approved	None posted
Sep 9, 1976	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 24, 1975	Supplement 6Labeling · Priority review	Approved	None posted
Mar 15, 1962	Original applicationNew active ingredient · Priority review	Approved	None posted

Identifiers

Application: NDA 12968
Drugs@FDA: Overview at FDA
Company: Bracco

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters