Chlorpropamide

ANDA 88826, held by Ani Pharms. Chlorpropamide.

As of Nov 13, 2026, ANDA 88826 (Chlorpropamide), held by Ani Pharms, was first approved by FDA on Sep 26, 1984, with 12 approved supplements and 0 published complete response letters.

First approved: Sep 26, 1984
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Sep 26, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorpropamide250MG · tablet;oral	Chlorpropamide	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 26, 1991	Supplement 14Labeling	Approved	None posted
Nov 27, 1991	Supplement 13Labeling	Approved	None posted
Jun 13, 1991	Supplement 12Manufacturing	Approved	None posted
May 31, 1991	Supplement 10Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 11Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 9Manufacturing	Approved	None posted
Jun 22, 1988	Supplement 8Labeling	Approved	None posted
Apr 25, 1988	Supplement 7Manufacturing	Approved	None posted
Apr 25, 1988	Supplement 6Manufacturing	Approved	None posted
Apr 28, 1987	Supplement 4Manufacturing	Approved	None posted
Oct 29, 1986	Supplement 2Manufacturing	Approved	None posted
Jul 19, 1985	Supplement 1Manufacturing	Approved	None posted
Sep 26, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88826
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