Acetazolamide

ANDA 40195, held by Taro. Acetazolamide.

As of Nov 13, 2026, ANDA 40195 (Acetazolamide), held by Taro, was first approved by FDA on May 28, 1997, with 1 approved supplement and 0 published complete response letters.

First approved: May 28, 1997
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 28, 1997	Original application	Approved	None posted

Products

2 strengths and forms


Acetazolamide125MG · tablet;oral	Acetazolamide	Rx
Acetazolamide250MG · tablet;oral	Acetazolamide	Rx

All 2 submissions, including labeling and manufacturing supplements


Jan 9, 2016	Supplement 7Labeling · Standard review	Approved	None posted
May 28, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 40195
Drugs@FDA: Overview at FDA
Company: Taro Pharmaceuticals

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