Col-Probenecid

Treats chronic gouty arthritis. ANDA 84279, held by Watson Labs. Colchicine; Probenecid.

As of Nov 15, 2026, ANDA 84279 (Col-Probenecid), held by Watson Labs, was first approved by FDA on Nov 23, 1976, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 23, 1976
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For the treatment of chronic gouty arthritis when complicated by frequent, recurrent acute attacks of gout.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Nov 23, 1976	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Col-Probenecid0.5MG;500MG · tablet;oral	Colchicine; Probenecid	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


May 6, 2002	Supplement 45Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 44Manufacturing	Approved	None posted
May 31, 1991	Supplement 41Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 42Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 39Manufacturing	Approved	None posted
Nov 30, 1989	Supplement 40Labeling	Approved	None posted
Mar 14, 1988	Supplement 36Manufacturing	Approved	None posted
Mar 14, 1988	Supplement 37Manufacturing	Approved	None posted
Mar 14, 1988	Supplement 38Manufacturing	Approved	None posted
Jan 22, 1985	Supplement 32Manufacturing	Approved	None posted
Feb 15, 1984	Supplement 31Manufacturing	Approved	None posted
Nov 9, 1983	Supplement 30Manufacturing	Approved	None posted
Jun 29, 1983	Supplement 27Manufacturing	Approved	None posted
Jun 29, 1983	Supplement 28Manufacturing	Approved	None posted
Jun 29, 1983	Supplement 29Manufacturing	Approved	None posted
Nov 30, 1982	Supplement 26Manufacturing	Approved	None posted
Jan 28, 1982	Supplement 25Manufacturing	Approved	None posted
Nov 23, 1976	Original application	Approved	Review

Identifiers

Application: ANDA 84279
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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