Ophthocort

NDA 50201, held by Parkedale. Chloramphenicol; Hydrocortisone Acetate; Polymyxin B Sulfate.

As of Nov 14, 2026, NDA 50201 (Ophthocort), held by Parkedale, was first approved by FDA on Jun 25, 1958, with 23 approved supplements and 0 published complete response letters.

First approved: Jun 25, 1958
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Jun 25, 1958	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ophthocort10MG/GM;5MG/GM;10,000 UNITS/GM · ointment;ophthalmic	Chloramphenicol; Hydrocortisone Acetate; Polymyxin B Sulfate	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Aug 27, 1996	Supplement 26Labeling · Standard review	Approved	None posted
Jun 17, 1992	Supplement 6Manufacturing	Approved	None posted
Nov 8, 1988	Supplement 4Labeling	Approved	None posted
Mar 25, 1988	Supplement 25Labeling	Approved	None posted
Sep 29, 1986	Supplement 5Manufacturing	Approved	None posted
Aug 15, 1983	Supplement 3Labeling	Approved	None posted
Jul 22, 1983	Supplement 2Manufacturing	Approved	None posted
Apr 19, 1983	Supplement 24Manufacturing	Approved	None posted
Apr 19, 1983	Supplement 1Manufacturing	Approved	None posted
Jul 7, 1982	Supplement 23Labeling	Approved	None posted
Dec 12, 1980	Supplement 22Labeling	Approved	None posted
Dec 8, 1980	Supplement 21Labeling	Approved	None posted
Jan 22, 1980	Supplement 19Labeling	Approved	None posted
Dec 20, 1979	Supplement 18Manufacturing	Approved	None posted
Aug 29, 1978	Supplement 17Labeling	Approved	None posted
Jun 5, 1978	Supplement 16Manufacturing	Approved	None posted
Jul 18, 1973	Supplement 15Labeling	Approved	None posted
Aug 30, 1972	Supplement 14Labeling	Approved	None posted
Aug 30, 1972	Supplement 13Labeling	Approved	None posted
Nov 9, 1970	Supplement 12Labeling	Approved	None posted
Dec 10, 1963	Supplement 11Labeling	Approved	None posted
May 19, 1961	Supplement 8Manufacturing	Approved	None posted
May 19, 1961	Supplement 7Manufacturing	Approved	None posted
Jun 25, 1958	Original application	Approved	None posted

Identifiers

Application: NDA 50201
Drugs@FDA: Overview at FDA
Company: Parkedale 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