Trimethoprim

ANDA 70494, held by Sun Pharm Industries. Trimethoprim.

As of Nov 14, 2026, ANDA 70494 (Trimethoprim), held by Sun Pharm Industries, was first approved by FDA on Jan 23, 1986, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 23, 1986
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jan 23, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trimethoprim100MG · tablet;oral	Trimethoprim	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Oct 30, 2015	Supplement 15Labeling · Standard review	Approved	None posted
Dec 1, 1998	Supplement 14Manufacturing	Approved	None posted
Feb 26, 1997	Supplement 13Labeling	Approved	None posted
Dec 23, 1994	Supplement 12Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 11Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 8Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 10Manufacturing	Approved	None posted
Apr 3, 1987	Supplement 4Manufacturing	Approved	None posted
Sep 5, 1986	Supplement 1Manufacturing	Approved	None posted
Sep 5, 1986	Supplement 2Manufacturing	Approved	None posted
Jan 23, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70494
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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