Trimethoprim

ANDA 70049, held by Watson Labs. Trimethoprim.

As of Nov 14, 2026, ANDA 70049 (Trimethoprim), held by Watson Labs, was first approved by FDA on Jun 6, 1985, with 11 approved supplements and 0 published complete response letters.

First approved: Jun 6, 1985
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
Jun 6, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trimethoprim100MG · tablet;oral	Trimethoprim	Rx

All 12 submissions, including labeling and manufacturing supplements


Oct 27, 2015	Supplement 31Labeling · Standard review	Approved	None posted
Feb 21, 2007	Supplement 15Labeling	Approved	None posted
May 1, 2002	Supplement 13Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 12Manufacturing	Approved	None posted
Feb 2, 2001	Supplement 11Labeling	Approved	None posted
Feb 26, 1997	Supplement 9Labeling	Approved	None posted
Dec 23, 1991	Supplement 8Manufacturing	Approved	None posted
Aug 7, 1991	Supplement 6Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 7Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 5Manufacturing	Approved	None posted
Dec 9, 1985	Supplement 1Manufacturing	Approved	None posted
Jun 6, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70049
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