Statrol

NDA 50344, held by Alcon. Neomycin Sulfate; Polymyxin B Sulfate.

As of Nov 14, 2026, NDA 50344 (Statrol), held by Alcon, was first approved by FDA on Mar 12, 1974, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 12, 1974
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Mar 12, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
StatrolEQ 3.5MG BASE/GM;10,000 UNITS/GM · ointment;ophthalmic	Neomycin Sulfate; Polymyxin B Sulfate	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Sep 28, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 5, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 9, 1997	Supplement 16Labeling · Standard review	Approved	None posted
Nov 29, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 18, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 28, 1993	Supplement 13Labeling · Standard review	Approved	None posted
Aug 24, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 3, 1992	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 31, 1991	Supplement 1Labeling	Approved	None posted
Mar 3, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 22, 1988	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 16, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 8, 1984	Supplement 10Labeling	Approved	None posted
Nov 23, 1983	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 23, 1983	Supplement 8Labeling	Approved	None posted
Apr 13, 1981	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 12, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 50344
Drugs@FDA: Overview at FDA
Company: Alcon

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