Cortisporin

NDA 50169, held by Monarch Pharms. Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate.

As of Nov 13, 2026, NDA 50169 (Cortisporin), held by Monarch Pharms, was first approved by FDA on Dec 18, 1964, with 33 approved supplements and 0 published complete response letters.

First approved: Dec 18, 1964
Supplements approved: 33
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below


Jan 16, 1981	Supplement 34Efficacy (new indication or use)	Approved	None posted
Dec 18, 1964	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cortisporin1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML · suspension/drops;ophthalmic	Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate	Discontinued

All 34 submissions, including labeling and manufacturing supplements


Nov 25, 2003	Supplement 46Labeling · Standard review	Approved	Letter Label
Apr 19, 1999	Supplement 45Manufacturing	Approved	None posted
Jun 13, 1995	Supplement 44Manufacturing	Approved	None posted
May 10, 1994	Supplement 9Labeling	Approved	None posted
Dec 13, 1985	Supplement 8Manufacturing	Approved	None posted
Aug 21, 1984	Supplement 7Manufacturing	Approved	None posted
Feb 28, 1984	Supplement 6Manufacturing	Approved	None posted
Mar 30, 1983	Supplement 1Labeling	Approved	None posted
Sep 13, 1982	Supplement 42Manufacturing	Approved	None posted
Mar 26, 1982	Supplement 41Manufacturing	Approved	None posted
Jan 26, 1982	Supplement 40Manufacturing	Approved	None posted
Oct 20, 1981	Supplement 37Manufacturing	Approved	None posted
Sep 15, 1981	Supplement 36Manufacturing	Approved	None posted
Jan 16, 1981	Supplement 34Efficacy (new indication or use)	Approved	None posted
Dec 1, 1980	Supplement 35Labeling	Approved	None posted
Nov 20, 1972	Supplement 31Labeling	Approved	None posted
Jul 6, 1972	Supplement 30Labeling	Approved	None posted
Jun 21, 1972	Supplement 28Labeling	Approved	None posted
May 11, 1971	Supplement 25Manufacturing	Approved	None posted
Dec 18, 1970	Supplement 24Labeling	Approved	None posted
Oct 9, 1970	Supplement 23Labeling	Approved	None posted
Jul 27, 1970	Supplement 22Labeling	Approved	None posted
Mar 25, 1969	Supplement 19Manufacturing	Approved	None posted
Mar 24, 1969	Supplement 17Manufacturing	Approved	None posted
Mar 17, 1969	Supplement 20Manufacturing	Approved	None posted
Jul 13, 1967	Supplement 16Labeling	Approved	None posted
Apr 20, 1967	Supplement 15Labeling	Approved	None posted
Apr 10, 1967	Supplement 14Labeling	Approved	None posted
Apr 4, 1967	Supplement 13Labeling	Approved	None posted
Oct 19, 1966	Supplement 12Labeling	Approved	None posted
Sep 13, 1966	Supplement 10Labeling	Approved	None posted
May 5, 1966	Supplement 3Labeling	Approved	None posted
Sep 30, 1965	Supplement 2Labeling	Approved	None posted
Dec 18, 1964	Original application	Approved	None posted

Identifiers

Application: NDA 50169
Drugs@FDA: Overview at FDA
Company: Monarch Pharmaceuticals

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