Oragrafin Sodium

NDA 12967, held by Bracco. Ipodate Sodium.

As of Nov 13, 2026, NDA 12967 (Oragrafin Sodium), held by Bracco, was first approved by FDA on Jun 25, 1962, with 22 approved supplements and 0 published complete response letters.

First approved: Jun 25, 1962
Review: Priority
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jun 25, 1962	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oragrafin Sodium500MG · capsule;oral	Ipodate Sodium	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Sep 17, 1992	Supplement 36Manufacturing · Priority review	Approved	None posted
Apr 13, 1988	Supplement 35Labeling · Priority review	Approved	None posted
Sep 25, 1986	Supplement 33Manufacturing · Priority review	Approved	None posted
Oct 25, 1985	Supplement 32Manufacturing · Priority review	Approved	None posted
Mar 29, 1985	Supplement 31Manufacturing · Priority review	Approved	None posted
Jun 30, 1982	Supplement 29Manufacturing · Priority review	Approved	None posted
Feb 10, 1982	Supplement 26Manufacturing · Priority review	Approved	None posted
Jan 18, 1980	Supplement 25Manufacturing · Priority review	Approved	None posted
Jan 18, 1980	Supplement 24Manufacturing · Priority review	Approved	None posted
Sep 13, 1979	Supplement 23Labeling · Priority review	Approved	None posted
Apr 17, 1979	Supplement 22Manufacturing · Priority review	Approved	None posted
Oct 25, 1978	Supplement 20Manufacturing · Priority review	Approved	None posted
Oct 20, 1978	Supplement 21Manufacturing · Priority review	Approved	None posted
Jun 7, 1978	Supplement 17Manufacturing · Priority review	Approved	None posted
Jun 7, 1978	Supplement 15Manufacturing · Priority review	Approved	None posted
May 23, 1978	Supplement 18Labeling · Priority review	Approved	None posted
Nov 1, 1977	Supplement 16Manufacturing · Priority review	Approved	None posted
May 11, 1976	Supplement 14Labeling · Priority review	Approved	None posted
Dec 30, 1975	Supplement 12Labeling · Priority review	Approved	None posted
Dec 30, 1975	Supplement 9Labeling · Priority review	Approved	None posted
Dec 19, 1975	Supplement 13Manufacturing · Priority review	Approved	None posted
Dec 19, 1975	Supplement 11Manufacturing · Priority review	Approved	None posted
Jun 25, 1962	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 12967
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