Imagent

NDA 20091, held by Alliance Pharm. Perflubron.

As of Nov 13, 2026, NDA 20091 (Imagent), held by Alliance Pharm, was first approved by FDA on Aug 13, 1993, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 13, 1993
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
Aug 13, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Imagent100% · liquid;oral	Perflubron	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 27, 1996	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 29, 1995	Supplement 4Manufacturing · Priority review	Approved	None posted
Sep 30, 1994	Supplement 2Manufacturing · Priority review	Approved	None posted
Sep 30, 1994	Supplement 3Manufacturing · Priority review	Approved	None posted
Sep 22, 1993	Supplement 1Labeling · Standard review	Approved	None posted
Aug 13, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20091
Drugs@FDA: Overview at FDA
Company: Alliance Pharmaceutical Corp.

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