Colbenemid

NDA 12383, held by Merck. Colchicine; Probenecid.

As of Nov 13, 2026, NDA 12383 (Colbenemid), held by Merck, was first approved by FDA on Jul 27, 1961, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 27, 1961
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jul 27, 1961	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Colbenemid0.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Colchicine; Probenecid	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Aug 18, 1994	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 20, 1994	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 30, 1989	Supplement 26Manufacturing · Standard review	Approved	None posted
May 12, 1988	Supplement 24Labeling · Standard review	Approved	None posted
May 12, 1988	Supplement 23Labeling · Standard review	Approved	None posted
May 12, 1988	Supplement 21Labeling · Standard review	Approved	None posted
Jul 23, 1985	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 2, 1982	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 21, 1981	Supplement 14Labeling · Standard review	Approved	None posted
Aug 24, 1979	Supplement 16Labeling · Standard review	Approved	None posted
May 30, 1979	Supplement 12Manufacturing · Standard review	Approved	None posted
May 10, 1979	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 1, 1978	Supplement 13Labeling · Standard review	Approved	None posted
Jul 27, 1961	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 12383
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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