Chlorpropamide

ANDA 88918, held by Ani Pharms. Chlorpropamide.

As of Nov 13, 2026, ANDA 88918 (Chlorpropamide), held by Ani Pharms, was first approved by FDA on Oct 16, 1984, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 16, 1984
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 16, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorpropamide100MG · tablet;oral	Chlorpropamide	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 23, 1989	Supplement 10Labeling	Approved	None posted
Oct 16, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88918
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