Chlorpropamide

ANDA 89446, held by Ani Pharms. Chlorpropamide.

As of Nov 13, 2026, ANDA 89446 (Chlorpropamide), held by Ani Pharms, was first approved by FDA on Nov 17, 1986, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 17, 1986
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 17, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorpropamide100MG · tablet;oral	Chlorpropamide	Discontinued

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 30, 1991	Supplement 8Labeling	Approved	None posted
May 17, 1989	Supplement 6Labeling	Approved	None posted
Mar 28, 1988	Supplement 5Labeling	Approved	None posted
Nov 17, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 89446
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