Cortisporin

NDA 50168, held by Monarch Pharms. Bacitracin Zinc; Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate.

As of Nov 14, 2026, NDA 50168 (Cortisporin), held by Monarch Pharms, was first approved by FDA on Mar 26, 1957, with 65 approved supplements and 0 published complete response letters.

First approved: Mar 26, 1957
Supplements approved: 65
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 66 submissions below

Date	Submission	Status	Documents
Mar 26, 1957	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cortisporin400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Bacitracin Zinc; Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate	DiscontinuedReference drug

All 66 submissions, including labeling and manufacturing supplements


Aug 8, 2025	Supplement 86Labeling · Standard review	Approved	Letter Label
Nov 21, 2003	Supplement 78Labeling · Standard review	Approved	Label Letter
Aug 13, 2001	Supplement 76Manufacturing	Approved	None posted
Jul 19, 1999	Supplement 73Labeling · Standard review	Approved	None posted
May 28, 1999	Supplement 75Manufacturing	Approved	None posted
Nov 4, 1998	Supplement 74Manufacturing	Approved	None posted
Sep 22, 1993	Supplement 9Manufacturing	Approved	None posted
May 16, 1986	Supplement 5Labeling	Approved	None posted
Apr 7, 1986	Supplement 6Manufacturing	Approved	None posted
Dec 4, 1985	Supplement 4Labeling	Approved	None posted
Jun 25, 1984	Supplement 2Labeling	Approved	None posted
Jul 6, 1983	Supplement 1Manufacturing	Approved	None posted
Mar 26, 1982	Supplement 70Manufacturing	Approved	None posted
Oct 20, 1981	Supplement 69Manufacturing	Approved	None posted
Jun 19, 1978	Supplement 67Manufacturing	Approved	None posted
May 6, 1977	Supplement 66Manufacturing	Approved	None posted
Jan 13, 1977	Supplement 65Labeling	Approved	None posted
Jun 16, 1974	Supplement 64Manufacturing	Approved	None posted
Apr 24, 1974	Supplement 63Labeling	Approved	None posted
Feb 12, 1974	Supplement 62Manufacturing	Approved	None posted
May 23, 1973	Supplement 56Labeling	Approved	None posted
Oct 17, 1972	Supplement 61Manufacturing	Approved	None posted
Oct 16, 1972	Supplement 60Labeling	Approved	None posted
Jul 5, 1972	Supplement 59Labeling	Approved	None posted
Jun 23, 1972	Supplement 58Labeling	Approved	None posted
May 10, 1971	Supplement 57Manufacturing	Approved	None posted
Aug 11, 1970	Supplement 52Manufacturing	Approved	None posted
Jul 24, 1970	Supplement 55Labeling	Approved	None posted
Jun 15, 1970	Supplement 54Labeling	Approved	None posted
May 25, 1970	Supplement 53Labeling	Approved	None posted
Apr 17, 1970	Supplement 51Labeling	Approved	None posted
Apr 7, 1970	Supplement 50Labeling	Approved	None posted
Jul 8, 1969	Supplement 49Labeling	Approved	None posted
Mar 4, 1969	Supplement 47Manufacturing	Approved	None posted
Aug 14, 1968	Supplement 46Manufacturing	Approved	None posted
Jul 2, 1968	Supplement 45Labeling	Approved	None posted
Dec 18, 1967	Supplement 44Labeling	Approved	None posted
Aug 11, 1967	Supplement 43Labeling	Approved	None posted
Jul 20, 1967	Supplement 42Labeling	Approved	None posted
Jul 20, 1967	Supplement 41Labeling	Approved	None posted
Apr 6, 1967	Supplement 40Labeling	Approved	None posted
Mar 20, 1967	Supplement 36Labeling	Approved	None posted
Mar 3, 1967	Supplement 38Labeling	Approved	None posted
Mar 3, 1967	Supplement 39Labeling	Approved	None posted
Feb 24, 1967	Supplement 37Labeling	Approved	None posted
Feb 10, 1967	Supplement 35Labeling	Approved	None posted
Jan 20, 1967	Supplement 34Labeling	Approved	None posted
Jan 13, 1967	Supplement 32Labeling	Approved	None posted
Nov 3, 1966	Supplement 30Labeling	Approved	None posted
Aug 26, 1966	Supplement 28Labeling	Approved	None posted
May 12, 1966	Supplement 25Labeling	Approved	None posted
Jun 8, 1965	Supplement 23Labeling	Approved	None posted
Apr 6, 1965	Supplement 22Labeling	Approved	None posted
Mar 22, 1965	Supplement 21Labeling	Approved	None posted
Jan 12, 1965	Supplement 20Labeling	Approved	None posted
Jan 11, 1965	Supplement 19Labeling	Approved	None posted
Jan 6, 1965	Supplement 18Labeling	Approved	None posted
Dec 22, 1964	Supplement 17Labeling	Approved	None posted
Oct 17, 1963	Supplement 15Labeling	Approved	None posted
Oct 4, 1963	Supplement 14Labeling	Approved	None posted
Jul 24, 1963	Supplement 12Labeling	Approved	None posted
Jun 1, 1962	Supplement 10Labeling	Approved	None posted
May 24, 1962	Supplement 7Labeling	Approved	None posted
May 24, 1962	Supplement 8Labeling	Approved	None posted
Sep 6, 1960	Supplement 3Manufacturing	Approved	None posted
Mar 26, 1957	Original application	Approved	None posted

Show all 66

Identifiers

Application: NDA 50168
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