Acetohexamide

ANDA 70870, held by Ani Pharms. Acetohexamide.

As of Nov 13, 2026, ANDA 70870 (Acetohexamide), held by Ani Pharms, was first approved by FDA on Feb 9, 1987, with 18 approved supplements and 0 published complete response letters.

First approved: Feb 9, 1987
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Feb 9, 1987	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Acetohexamide500MG · tablet;oral	Acetohexamide	Discontinued
Acetohexamide250MG · tablet;oral	Acetohexamide	Discontinued

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 13, 2002	Supplement 21Manufacturing	Approved	None posted
Oct 26, 2001	Supplement 20Labeling	Approved	None posted
Dec 21, 1999	Supplement 19Manufacturing	Approved	None posted
May 21, 1999	Supplement 18Manufacturing	Approved	None posted
May 20, 1999	Supplement 17Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 16Manufacturing	Approved	None posted
May 3, 1995	Supplement 15Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 14Manufacturing	Approved	None posted
Nov 29, 1994	Supplement 13Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 12Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 11Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 9Manufacturing	Approved	None posted
Oct 28, 1991	Supplement 8Labeling	Approved	None posted
Sep 11, 1991	Supplement 7Labeling	Approved	None posted
Aug 2, 1991	Supplement 4Manufacturing	Approved	None posted
Aug 2, 1991	Supplement 3Manufacturing	Approved	None posted
Dec 13, 1990	Supplement 6Bioequivalence	Approved	None posted
Mar 31, 1987	Supplement 1Manufacturing	Approved	None posted
Feb 9, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70870
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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