Trimethoprim

ANDA 70495, held by Sun Pharm Industries. Trimethoprim.

As of Nov 14, 2026, ANDA 70495 (Trimethoprim), held by Sun Pharm Industries, was first approved by FDA on Mar 14, 1986, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 14, 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
Mar 14, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trimethoprim200MG · tablet;oral	Trimethoprim	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Oct 30, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Dec 1, 1998	Supplement 12Manufacturing	Approved	None posted
Feb 26, 1997	Supplement 11Labeling	Approved	None posted
Dec 23, 1994	Supplement 10Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 9Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 8Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 6Manufacturing	Approved	None posted
Mar 31, 1987	Supplement 3Manufacturing	Approved	None posted
Sep 5, 1986	Supplement 2Manufacturing	Approved	None posted
Sep 5, 1986	Supplement 1Manufacturing	Approved	None posted
Mar 14, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70495
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