Ethamide

NDA 16144, held by Allergan. Ethoxzolamide.

As of Nov 14, 2026, NDA 16144 (Ethamide), held by Allergan, was first approved by FDA on Oct 12, 1966, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 12, 1966
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 12, 1966	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ethamide125MG · tablet;oral	Ethoxzolamide	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Aug 5, 1996	Supplement 7Labeling	Approved	None posted
Oct 13, 1978	Supplement 11Labeling	Approved	None posted
Oct 12, 1978	Supplement 9Labeling	Approved	None posted
Oct 12, 1978	Supplement 10Labeling	Approved	None posted
Dec 9, 1974	Supplement 8Labeling	Approved	None posted
Oct 12, 1966	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16144
Drugs@FDA: Overview at FDA
Company: Allergan

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