Probenecid And Colchicine

ANDA 83734, held by Ani Pharms. Colchicine; Probenecid.

As of Nov 15, 2026, ANDA 83734 (Probenecid And Colchicine), held by Ani Pharms, was first approved by FDA on Jun 12, 1978, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 12, 1978
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jun 12, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Probenecid And Colchicine0.5MG;500MG · tablet;oral	Colchicine; Probenecid	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Jul 29, 2002	Supplement 47Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 46Manufacturing	Approved	None posted
Jul 11, 2001	Supplement 44Manufacturing	Approved	None posted
Jul 11, 2001	Supplement 42Manufacturing	Approved	None posted
Jul 11, 2001	Supplement 41Manufacturing	Approved	None posted
Jul 11, 2001	Supplement 40Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 43Manufacturing	Approved	None posted
Aug 20, 1999	Supplement 39Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 38Manufacturing	Approved	None posted
May 30, 1997	Supplement 37Manufacturing	Approved	None posted
Feb 5, 1996	Supplement 35Manufacturing	Approved	None posted
Aug 3, 1993	Supplement 36Manufacturing	Approved	None posted
Jan 5, 1990	Supplement 34Labeling	Approved	None posted
Jan 20, 1988	Supplement 33Manufacturing	Approved	None posted
Jan 20, 1988	Supplement 32Manufacturing	Approved	None posted
Jan 20, 1988	Supplement 31Manufacturing	Approved	None posted
Mar 3, 1987	Supplement 30Manufacturing	Approved	None posted
Mar 3, 1987	Supplement 29Manufacturing	Approved	None posted
Jun 12, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 83734
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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