Bactrim

NDA 18374, held by Sun Pharm Inds Inc. Sulfamethoxazole; Trimethoprim.

As of Nov 13, 2026, NDA 18374 (Bactrim), held by Sun Pharm Inds Inc, was first approved by FDA on Jun 23, 1981, with 24 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1981
Review: Priority
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Jun 23, 1981	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bactrim80MG/ML;16MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Sulfamethoxazole; Trimethoprim	DiscontinuedReference drug

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 21, 2025	Supplement 29Labeling · Standard review	Approved	Letter Label
May 21, 2021	Supplement 28Labeling · Standard review	Approved	Label Letter
Jul 29, 2020	Supplement 27Labeling · Standard review	Approved	Letter Label
Feb 9, 2018	Supplement 26Labeling · Standard review	Approved	Letter Label
Mar 4, 2017	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 13, 2001	Supplement 24Manufacturing · Priority review	Approved	None posted
Oct 21, 1997	Supplement 22Manufacturing · Priority review	Approved	None posted
Aug 19, 1997	Supplement 21Manufacturing · Priority review	Approved	None posted
Mar 6, 1996	Supplement 15Labeling	Approved	None posted
Jun 23, 1992	Supplement 19Manufacturing · Priority review	Approved	None posted
Nov 5, 1991	Supplement 20Manufacturing · Priority review	Approved	None posted
Nov 3, 1987	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 2, 1987	Supplement 11Labeling	Approved	None posted
Aug 11, 1987	Supplement 14Labeling	Approved	None posted
Aug 5, 1985	Supplement 13Manufacturing · Priority review	Approved	None posted
Jul 22, 1985	Supplement 12Manufacturing · Priority review	Approved	None posted
Nov 23, 1984	Supplement 10Labeling	Approved	None posted
Apr 2, 1984	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 30, 1983	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 30, 1983	Supplement 8Manufacturing · Priority review	Approved	None posted
Sep 24, 1982	Supplement 5Manufacturing · Priority review	Approved	None posted
May 13, 1982	Supplement 3Manufacturing · Priority review	Approved	None posted
Sep 28, 1981	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 28, 1981	Supplement 2Manufacturing · Priority review	Approved	None posted
Jun 23, 1981	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 18374
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