Acetazolamide

ANDA 88882, held by Heritage Pharma. Acetazolamide.

As of Nov 13, 2026, ANDA 88882 (Acetazolamide), held by Heritage Pharma, was first approved by FDA on Oct 22, 1985, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 22, 1985
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 22, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetazolamide250MG · tablet;oral	Acetazolamide	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Apr 25, 2001	Supplement 11Manufacturing	Approved	None posted
Jun 3, 1991	Supplement 9Labeling	Approved	None posted
May 31, 1991	Supplement 7Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 8Manufacturing	Approved	None posted
May 15, 1989	Supplement 4Manufacturing	Approved	None posted
May 15, 1989	Supplement 5Manufacturing	Approved	None posted
Jun 15, 1988	Supplement 3Manufacturing	Approved	None posted
Oct 22, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88882
Drugs@FDA: Overview at FDA
Company: Heritage 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