Sulfamethoxazole And Trimethoprim

NDA 18852, held by Watson Labs. Sulfamethoxazole; Trimethoprim.

As of Nov 13, 2026, NDA 18852 (Sulfamethoxazole And Trimethoprim), held by Watson Labs, was first approved by FDA on May 9, 1983, with 18 approved supplements and 0 published complete response letters.

First approved: May 9, 1983
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
May 9, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfamethoxazole And Trimethoprim400MG;80MG · tablet;oral	Sulfamethoxazole; Trimethoprim	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Dec 12, 2001	Supplement 26Labeling	Approved	None posted
Jun 27, 2001	Supplement 24Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 25Manufacturing	Approved	None posted
Jul 31, 2000	Supplement 23Manufacturing	Approved	None posted
Oct 21, 1997	Supplement 21Labeling	Approved	None posted
Feb 9, 1994	Supplement 20Labeling	Approved	None posted
Feb 25, 1993	Supplement 19Manufacturing	Approved	None posted
Aug 7, 1991	Supplement 17Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 18Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 16Manufacturing	Approved	None posted
Feb 22, 1990	Supplement 15Labeling	Approved	None posted
Sep 1, 1988	Supplement 14Manufacturing	Approved	None posted
Apr 11, 1988	Supplement 13Labeling	Approved	None posted
Mar 9, 1988	Supplement 11Manufacturing	Approved	None posted
Mar 9, 1988	Supplement 12Manufacturing	Approved	None posted
Jan 13, 1988	Supplement 9Manufacturing	Approved	None posted
Jan 13, 1988	Supplement 10Manufacturing	Approved	None posted
Oct 17, 1985	Supplement 7Manufacturing	Approved	None posted
May 9, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 18852
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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