Chlorpropamide

ANDA 88813, held by Ani Pharms. Chlorpropamide.

As of Nov 13, 2026, ANDA 88813 (Chlorpropamide), held by Ani Pharms, was first approved by FDA on Oct 19, 1984, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 19, 1984
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
Oct 19, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorpropamide250MG · tablet;oral	Chlorpropamide	Discontinued

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 16, 1991	Supplement 16Labeling	Approved	None posted
May 19, 1989	Supplement 15Labeling	Approved	None posted
May 9, 1988	Supplement 14Labeling	Approved	None posted
Oct 19, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88813
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