Phosphocol P32

NDA 17084, held by Curium. Chromic Phosphate P-32.

As of Nov 13, 2026, NDA 17084 (Phosphocol P32), held by Curium, was first approved by FDA on Sep 23, 1974, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 23, 1974
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Sep 23, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phosphocol P325mCi/ML · injectable;injection	Chromic Phosphate P-32	Discontinued

All 15 submissions, including labeling and manufacturing supplements


May 22, 2009	Supplement 17Labeling · Standard review	Approved	Letter Label
Aug 29, 2008	Supplement 16Labeling · Standard review	Approved	Letter Label
Aug 28, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 22, 1998	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 30, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
May 10, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 24, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 31, 1983	Supplement 8Manufacturing · Standard review	Approved	None posted
May 7, 1982	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 23, 1977	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 27, 1977	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 29, 1977	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 29, 1977	Supplement 1Labeling	Approved	None posted
Sep 23, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17084
Drugs@FDA: Overview at FDA
Company: Curium

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