Polytrim

NDA 50567, held by Allergan. Polymyxin B Sulfate; Trimethoprim Sulfate.

As of Nov 13, 2026, NDA 50567 (Polytrim), held by Allergan, was first approved by FDA on Oct 20, 1988, with 19 approved supplements and 0 published complete response letters.

First approved: Oct 20, 1988
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Oct 20, 1988	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Polytrim10,000 UNITS/ML;EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Polymyxin B Sulfate; Trimethoprim Sulfate	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 4, 2025	Supplement 28Labeling · Standard review	Approved	Label Letter
Mar 19, 2003	Supplement 22Labeling · Standard review	Approved	None posted
Apr 12, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 4, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 12, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 18, 2000	Supplement 16Labeling · Standard review	Approved	None posted
Dec 5, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 2, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 2, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
May 19, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 4, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 23, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 31, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 2, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 3, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 2, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 17, 1993	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 8, 1992	Supplement 3Labeling	Approved	None posted
Oct 20, 1988	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 50567
Drugs@FDA: Overview at FDA
Company: Allergan

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