Glutethimide

ANDA 89459, held by Halsey. Glutethimide.

As of Nov 15, 2026, ANDA 89459 (Glutethimide), held by Halsey, was first approved by FDA on Oct 10, 1986, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 10, 1986
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 10, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Glutethimide500MG · tablet;oral	Glutethimide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 29, 1993	Supplement 2Labeling	Approved	None posted
Oct 10, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 89459
Drugs@FDA: Overview at FDA
Company: Halsey Drug Co.

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