Acetazolamide

ANDA 87654, held by Vangard. Acetazolamide.

As of Nov 13, 2026, ANDA 87654 (Acetazolamide), held by Vangard, was first approved by FDA on Feb 5, 1982, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 5, 1982
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
Feb 5, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetazolamide250MG · tablet;oral	Acetazolamide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Apr 6, 1987	Supplement 3Manufacturing	Approved	None posted
Feb 5, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87654
Drugs@FDA: Overview at FDA
Company: Vangard Labs

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