Acetazolamide Sodium

ANDA 40108, held by Hospira. Acetazolamide Sodium.

As of Nov 15, 2026, ANDA 40108 (Acetazolamide Sodium), held by Hospira, was first approved by FDA on Oct 30, 1995, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 30, 1995
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
Oct 30, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acetazolamide SodiumEQ 500MG BASE/VIAL · injectable;injection	Acetazolamide Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 14, 2001	Supplement 1Manufacturing	Approved	None posted
Oct 30, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 40108
Drugs@FDA: Overview at FDA
Company: Hospira

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