Acetazolamide

ANDA 84840, held by Chartwell Molecular. Acetazolamide.

As of Nov 13, 2026, ANDA 84840 (Acetazolamide), held by Chartwell Molecular, was first approved by FDA on Mar 31, 1978, with 13 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1978
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Mar 31, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetazolamide250MG · tablet;oral	Acetazolamide	Rx

All 14 submissions, including labeling and manufacturing supplements


Oct 24, 2016	Supplement 26Manufacturing	Approved	None posted
May 29, 2008	Supplement 23Labeling	Approved	None posted
Dec 12, 2001	Supplement 19Labeling	Approved	None posted
Aug 10, 2000	Supplement 18Manufacturing	Approved	None posted
Jul 26, 1996	Supplement 13Manufacturing	Approved	None posted
Jul 26, 1996	Supplement 14Manufacturing	Approved	None posted
Jul 26, 1996	Supplement 15Manufacturing	Approved	None posted
Jul 26, 1996	Supplement 16Labeling	Approved	None posted
Jul 26, 1996	Supplement 17Manufacturing	Approved	None posted
Jun 27, 1994	Supplement 7Manufacturing	Approved	None posted
Jun 5, 1990	Supplement 11Labeling	Approved	None posted
May 4, 1988	Supplement 8Labeling	Approved	None posted
Nov 16, 1981	Supplement 3Manufacturing	Approved	None posted
Mar 31, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 84840
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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