Chlorpropamide

ANDA 88549, held by Pharmobedient. Chlorpropamide.

As of Nov 13, 2026, ANDA 88549 (Chlorpropamide), held by Pharmobedient, was first approved by FDA on Jun 1, 1984, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 1, 1984
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 1, 1984	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Chlorpropamide250MG · tablet;oral	Chlorpropamide	Discontinued
Chlorpropamide100MG · tablet;oral	Chlorpropamide	Discontinued

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 16, 2009	Supplement 18Labeling	Approved	None posted
Aug 6, 2003	Supplement 14Labeling	Approved	None posted
Feb 25, 1998	Supplement 13Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 12Manufacturing	Approved	None posted
Jul 7, 1997	Supplement 11Manufacturing	Approved	None posted
Nov 3, 1993	Supplement 10Manufacturing	Approved	None posted
Jun 11, 1991	Supplement 8Labeling	Approved	None posted
Jan 31, 1990	Supplement 7Manufacturing	Approved	None posted
Jul 31, 1989	Supplement 6Labeling	Approved	None posted
Mar 4, 1988	Supplement 5Manufacturing	Approved	None posted
Jun 1, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88549
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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