Metimyd

NDA 10210, held by Schering. Prednisolone Acetate; Sulfacetamide Sodium.

As of Nov 14, 2026, NDA 10210 (Metimyd), held by Schering, was first approved by FDA on Jun 23, 1965, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1965
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jun 23, 1965	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms


Metimyd0.5%;10% · suspension/drops;ophthalmic	Prednisolone Acetate; Sulfacetamide Sodium	Discontinued
Metimyd0.5%;10% · ointment;ophthalmic	Prednisolone Acetate; Sulfacetamide Sodium	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Oct 1, 1999	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 21, 1997	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 26, 1997	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 13, 1996	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 30, 1994	Supplement 19Labeling · Standard review	Approved	None posted
Apr 6, 1989	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 3, 1989	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 23, 1988	Supplement 8Labeling · Standard review	Approved	None posted
Mar 23, 1988	Supplement 7Labeling · Standard review	Approved	None posted
Mar 23, 1988	Supplement 6Labeling · Standard review	Approved	None posted
May 12, 1987	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 16, 1987	Supplement 15Manufacturing · Standard review	Approved	None posted
May 20, 1986	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 28, 1986	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 28, 1986	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 11, 1986	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 9, 1984	Supplement 10Labeling · Standard review	Approved	None posted
Sep 9, 1984	Supplement 9Labeling · Standard review	Approved	None posted
Jun 23, 1965	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 10210
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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