Tolazamide

As of Nov 14, 2026, NDA 18894 (Tolazamide), held by Cosette, was first approved by FDA on Oct 3, 1984, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 3, 1984
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Oct 3, 1984	Original application	Approved	None posted

Products

3 strengths and forms


Tolazamide100MG · tablet;oral	Tolazamide	Discontinued
Tolazamide250MG · tablet;oral	Tolazamide	Discontinued
Tolazamide500MG · tablet;oral	Tolazamide	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jul 29, 2002	Supplement 19Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 18Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 16Manufacturing	Approved	None posted
Aug 18, 1998	Supplement 15Manufacturing	Approved	None posted
Dec 7, 1995	Supplement 12Manufacturing	Approved	None posted
Dec 7, 1995	Supplement 11Manufacturing	Approved	None posted
Jun 30, 1995	Supplement 10Labeling	Approved	None posted
Jun 13, 1994	Supplement 9Labeling	Approved	None posted
Nov 28, 1986	Supplement 6Manufacturing	Approved	None posted
Jun 9, 1986	Supplement 5Manufacturing	Approved	None posted
Mar 13, 1986	Supplement 4Manufacturing	Approved	None posted
Oct 3, 1984	Original application	Approved	None posted

Identifiers

Application: NDA 18894
Drugs@FDA: Overview at FDA
Company: Cosette

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