Bilopaque

NDA 13731, held by Ge Healthcare. Tyropanoate Sodium.

As of Nov 13, 2026, NDA 13731 (Bilopaque), held by Ge Healthcare, was first approved by FDA on Oct 24, 1969, with 20 approved supplements and 0 published complete response letters.

First approved: Oct 24, 1969
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Oct 24, 1969	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bilopaque750MG · capsule;oral	Tyropanoate Sodium	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Feb 22, 1995	Supplement 30Manufacturing · Standard review	Approved	None posted
Feb 21, 1991	Supplement 31Manufacturing · Standard review	Approved	None posted
Feb 21, 1990	Supplement 29Manufacturing · Standard review	Approved	None posted
Feb 22, 1988	Supplement 28Labeling · Standard review	Approved	None posted
May 20, 1987	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 18, 1986	Supplement 26Labeling · Standard review	Approved	None posted
Jul 11, 1986	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 7, 1984	Supplement 24Labeling · Standard review	Approved	None posted
Jul 11, 1984	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 1, 1984	Supplement 21Labeling · Standard review	Approved	None posted
Jun 30, 1982	Supplement 20Labeling · Standard review	Approved	None posted
Feb 8, 1982	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 25, 1980	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 29, 1979	Supplement 18Manufacturing · Standard review	Approved	None posted
May 14, 1979	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 28, 1978	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 30, 1978	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 15, 1977	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 8, 1977	Supplement 12Labeling · Standard review	Approved	None posted
May 11, 1976	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 24, 1969	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 13731
Drugs@FDA: Overview at FDA
Company: GE Healthcare

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