Methazolamide

Treats ocular conditions. ANDA 40062, held by Pharmobedient. Methazolamide.

As of Nov 15, 2026, ANDA 40062 (Methazolamide), held by Pharmobedient, was first approved by FDA on Jan 27, 1994, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 27, 1994
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Methazolamide Tablets USP is indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jan 27, 1994	Original application	Approved	None posted

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Aug 13, 2002	Supplement 3Manufacturing	Approved	None posted
Jul 31, 1998	Supplement 2Manufacturing	Approved	None posted
Feb 8, 1995	Supplement 1Manufacturing	Approved	None posted
Jan 27, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 40062
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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