Acetazolamide

ANDA 204691, held by Mpp Pharma. Acetazolamide.

As of Nov 13, 2026, ANDA 204691 (Acetazolamide), held by Mpp Pharma, was first approved by FDA on Mar 29, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 29, 2016
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Mar 29, 2016	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


Dec 12, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Jun 6, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Mar 29, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 204691
Drugs@FDA: Overview at FDA
Company: MPP 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