Diamox

NDA 8943, held by Teva Branded Pharm. Acetazolamide.

As of Nov 14, 2026, NDA 8943 (Diamox), held by Teva Branded Pharm, was first approved by FDA on Jul 27, 1953, with 37 approved supplements and 0 published complete response letters.

First approved: Jul 27, 1953
Review: Priority
Supplements approved: 37
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below

Date	Submission	Status	Documents
Jul 27, 1953	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Diamox125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Acetazolamide	DiscontinuedReference drug
Diamox250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Acetazolamide	DiscontinuedReference drug

All 38 submissions, including labeling and manufacturing supplements


Oct 1, 2025	Supplement 54Labeling · Standard review	Approved	Letter Label
Sep 20, 2024	Supplement 53Labeling · Standard review	Approved	Letter Label
May 13, 2022	Supplement 52Labeling · Standard review	Approved	Label Letter
Jan 5, 1999	Supplement 48Manufacturing · Priority review	Approved	None posted
Feb 14, 1991	Supplement 47Manufacturing · Priority review	Approved	None posted
Nov 28, 1990	Supplement 46Labeling	Approved	None posted
Apr 23, 1990	Supplement 45Manufacturing · Priority review	Approved	None posted
Jan 24, 1990	Supplement 44Labeling	Approved	None posted
Dec 6, 1989	Supplement 43Labeling	Approved	None posted
Jul 21, 1988	Supplement 42Manufacturing · Priority review	Approved	None posted
Jun 22, 1988	Supplement 41Labeling	Approved	None posted
Oct 6, 1987	Supplement 38Manufacturing · Priority review	Approved	None posted
Aug 11, 1987	Supplement 40Labeling	Approved	None posted
Jun 16, 1987	Supplement 39Manufacturing · Priority review	Approved	None posted
Mar 3, 1987	Supplement 37Labeling	Approved	None posted
Mar 21, 1986	Supplement 36Labeling	Approved	None posted
May 13, 1985	Supplement 35Labeling	Approved	None posted
Sep 25, 1984	Supplement 34Manufacturing · Priority review	Approved	None posted
Feb 22, 1984	Supplement 33Manufacturing · Priority review	Approved	None posted
Feb 14, 1984	Supplement 25Manufacturing · Priority review	Approved	None posted
Sep 29, 1982	Supplement 32Manufacturing · Priority review	Approved	None posted
Apr 2, 1982	Supplement 31Manufacturing · Priority review	Approved	None posted
Jun 12, 1981	Supplement 30Manufacturing · Priority review	Approved	None posted
Dec 17, 1980	Supplement 29Manufacturing · Priority review	Approved	None posted
Dec 17, 1980	Supplement 28Manufacturing · Priority review	Approved	None posted
Dec 17, 1980	Supplement 27Manufacturing · Priority review	Approved	None posted
Aug 30, 1979	Supplement 26Manufacturing · Priority review	Approved	None posted
Jul 31, 1979	Supplement 24Manufacturing · Priority review	Approved	None posted
Oct 2, 1978	Supplement 23Labeling	Approved	None posted
Apr 7, 1978	Supplement 22Manufacturing · Priority review	Approved	None posted
Apr 3, 1978	Supplement 21Manufacturing · Priority review	Approved	None posted
Jan 9, 1978	Supplement 20Manufacturing · Priority review	Approved	None posted
Jun 29, 1977	Supplement 19Manufacturing · Priority review	Approved	None posted
Jun 29, 1977	Supplement 18Manufacturing · Priority review	Approved	None posted
Jun 6, 1977	Supplement 17Manufacturing · Priority review	Approved	None posted
Jan 28, 1977	Supplement 15Manufacturing · Priority review	Approved	None posted
Jan 28, 1977	Supplement 13Manufacturing · Priority review	Approved	None posted
Jul 27, 1953	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 8943
Drugs@FDA: Overview at FDA
Company: Teva Branded Pharmaceutical Products

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