Sulfamethoxazole And Trimethoprim Double Strength

NDA 18854, held by Watson Labs. Sulfamethoxazole; Trimethoprim.

As of Nov 14, 2026, NDA 18854 (Sulfamethoxazole And Trimethoprim Double Strength), held by Watson Labs, was first approved by FDA on May 9, 1983, with 27 approved supplements and 0 published complete response letters.

First approved: May 9, 1983
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 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 Trimethoprim Double Strength800MG;160MG · tablet;oral	Sulfamethoxazole; Trimethoprim	Discontinued

All 28 submissions, including labeling and manufacturing supplements


Dec 12, 2001	Supplement 37Labeling	Approved	None posted
Jun 27, 2001	Supplement 35Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 36Manufacturing	Approved	None posted
Jul 31, 2000	Supplement 34Manufacturing	Approved	None posted
Aug 3, 1998	Supplement 32Manufacturing	Approved	None posted
Aug 3, 1998	Supplement 31Manufacturing	Approved	None posted
Aug 3, 1998	Supplement 30Manufacturing	Approved	None posted
Oct 21, 1997	Supplement 29Labeling	Approved	None posted
Jun 17, 1994	Supplement 28Labeling	Approved	None posted
Feb 9, 1994	Supplement 27Labeling	Approved	None posted
Feb 25, 1993	Supplement 26Manufacturing	Approved	None posted
Jan 29, 1992	Supplement 24Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 25Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 23Manufacturing	Approved	None posted
Nov 1, 1988	Supplement 21Manufacturing	Approved	None posted
Nov 1, 1988	Supplement 20Manufacturing	Approved	None posted
Oct 26, 1988	Supplement 22Bioequivalence	Approved	None posted
Sep 1, 1988	Supplement 19Manufacturing	Approved	None posted
Mar 17, 1988	Supplement 18Manufacturing	Approved	None posted
Mar 9, 1988	Supplement 17Manufacturing	Approved	None posted
Mar 9, 1988	Supplement 16Manufacturing	Approved	None posted
Jan 13, 1988	Supplement 15Manufacturing	Approved	None posted
Jan 13, 1988	Supplement 14Manufacturing	Approved	None posted
Jan 13, 1988	Supplement 13Manufacturing	Approved	None posted
Oct 17, 1985	Supplement 8Manufacturing	Approved	None posted
Oct 3, 1985	Supplement 9Manufacturing	Approved	None posted
Oct 31, 1984	Supplement 6Manufacturing	Approved	None posted
May 9, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 18854
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