Dymelor

NDA 13378, held by Lilly. Acetohexamide.

As of Nov 13, 2026, NDA 13378 (Dymelor), held by Lilly, was first approved by FDA on Dec 23, 1964, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1964
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Dec 23, 1964	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Dymelor500MG · tablet;oral	Acetohexamide	Discontinued
Dymelor250MG · tablet;oral	Acetohexamide	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Oct 19, 1998	Supplement 32Manufacturing · Priority review	Approved	None posted
Jun 16, 1998	Supplement 31Manufacturing · Priority review	Approved	None posted
Nov 27, 1990	Supplement 30Labeling	Approved	None posted
Dec 29, 1988	Supplement 29Labeling	Approved	None posted
Jan 30, 1987	Supplement 28Labeling	Approved	None posted
Sep 15, 1986	Supplement 27Manufacturing · Priority review	Approved	None posted
May 2, 1986	Supplement 26Labeling	Approved	None posted
Mar 18, 1986	Supplement 25Manufacturing · Priority review	Approved	None posted
Feb 14, 1985	Supplement 24Labeling	Approved	None posted
Jan 31, 1983	Supplement 22Manufacturing · Priority review	Approved	None posted
Feb 23, 1981	Supplement 18Labeling	Approved	None posted
Oct 14, 1980	Supplement 19Manufacturing · Priority review	Approved	None posted
Mar 21, 1980	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 27, 1979	Supplement 16Manufacturing · Priority review	Approved	None posted
Jan 9, 1979	Supplement 15Labeling	Approved	None posted
Sep 15, 1976	Supplement 14Manufacturing · Priority review	Approved	None posted
Jul 21, 1976	Supplement 13Manufacturing · Priority review	Approved	None posted
Dec 23, 1964	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 13378
Drugs@FDA: Overview at FDA
Company: Lilly

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