Acetazolamide

ANDA 90779, held by Indicus Pharma. Acetazolamide.

As of Nov 13, 2026, ANDA 90779 (Acetazolamide), held by Indicus Pharma, was first approved by FDA on Jul 14, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 14, 2011
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide is also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 14, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetazolamide500MG · capsule, extended release;oral	Acetazolamide	Rx

All 3 submissions, including labeling and manufacturing supplements


Sep 21, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Sep 21, 2026	Supplement 12Labeling · Standard review	Approved	None posted
Jul 14, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90779
Drugs@FDA: Overview at FDA
Company: Indicus Pharma

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