Acetohexamide

ANDA 71894, held by Watson Labs Teva. Acetohexamide.

As of Nov 13, 2026, ANDA 71894 (Acetohexamide), held by Watson Labs Teva, was first approved by FDA on Nov 25, 1987, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 25, 1987
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 25, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetohexamide500MG · tablet;oral	Acetohexamide	Discontinued

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 25, 1997	Supplement 6Manufacturing	Approved	None posted
Oct 30, 1996	Supplement 5Manufacturing	Approved	None posted
Sep 9, 1991	Supplement 4Labeling	Approved	None posted
May 31, 1991	Supplement 2Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 3Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 1Manufacturing	Approved	None posted
Nov 25, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71894
Drugs@FDA: Overview at FDA
Company: Watson Labs Teva

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters