Methazolamide

ANDA 40036, held by Chartwell Rx. Methazolamide.

As of Nov 15, 2026, ANDA 40036 (Methazolamide), held by Chartwell Rx, was first approved by FDA on Jun 30, 1993, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1993
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 30, 1993	Original application	Approved	None posted

Products

2 strengths and forms


Methazolamide25MG · tablet;oral	Methazolamide	Rx
Methazolamide50MG · tablet;oral	Methazolamide	Rx

All 11 submissions, including labeling and manufacturing supplements


Mar 25, 2002	Supplement 10Manufacturing	Approved	None posted
Aug 13, 2001	Supplement 9Manufacturing	Approved	None posted
Dec 29, 2000	Supplement 8Manufacturing	Approved	None posted
Dec 27, 2000	Supplement 7Manufacturing	Approved	None posted
Sep 11, 2000	Supplement 6Manufacturing	Approved	None posted
May 5, 1999	Supplement 5Manufacturing	Approved	None posted
Feb 11, 1999	Supplement 4Manufacturing	Approved	None posted
Sep 25, 1998	Supplement 3Manufacturing	Approved	None posted
Aug 11, 1997	Supplement 2Manufacturing	Approved	None posted
Apr 10, 1996	Supplement 1Manufacturing	Approved	None posted
Jun 30, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 40036
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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