Cortisporin

NDA 50479, held by Monarch Pharms. Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate.

As of Nov 13, 2026, NDA 50479 (Cortisporin), held by Monarch Pharms, was first approved by FDA on Dec 9, 1975, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 9, 1975
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Aug 26, 1999	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review
Dec 9, 1975	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cortisporin1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;otic	Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Aug 8, 2025	Supplement 21Labeling · Standard review	Approved	Letter Label
May 28, 2021	Supplement 20Manufacturing	Approved	Label
Aug 26, 1999	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review
Jun 28, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 15, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 21, 1996	Supplement 12Labeling	Approved	None posted
Nov 19, 1987	Supplement 6Labeling	Approved	None posted
Apr 1, 1987	Supplement 5Labeling	Approved	None posted
Aug 8, 1986	Supplement 4Labeling	Approved	None posted
Dec 13, 1985	Supplement 3Labeling	Approved	None posted
Aug 20, 1984	Supplement 2Labeling	Approved	None posted
Jul 6, 1983	Supplement 1Labeling	Approved	None posted
Jan 4, 1980	Supplement 11Labeling	Approved	None posted
Oct 9, 1979	Supplement 10Labeling	Approved	None posted
Oct 18, 1976	Supplement 9Labeling	Approved	None posted
Jun 22, 1976	Supplement 8Labeling	Approved	None posted
Jan 29, 1976	Supplement 7Labeling	Approved	None posted
Dec 9, 1975	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 50479
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