Cetamide

ANDA 80021, held by Alcon. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 80021 (Cetamide), held by Alcon, was first approved by FDA on Sep 27, 1972, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 27, 1972
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Sep 27, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cetamide10% · ointment;ophthalmic	Sulfacetamide Sodium	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Jan 18, 2000	Supplement 17Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 16Manufacturing	Approved	None posted
Dec 12, 1996	Supplement 15Manufacturing	Approved	None posted
Apr 18, 1996	Supplement 14Manufacturing	Approved	None posted
Apr 18, 1996	Supplement 13Manufacturing	Approved	None posted
Aug 23, 1994	Supplement 12Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 11Labeling	Approved	None posted
Aug 31, 1993	Supplement 9Labeling	Approved	None posted
Aug 19, 1992	Supplement 10Manufacturing	Approved	None posted
Jul 5, 1991	Supplement 8Labeling	Approved	None posted
Mar 9, 1990	Supplement 7Manufacturing	Approved	None posted
Mar 9, 1990	Supplement 5Manufacturing	Approved	None posted
Sep 15, 1989	Supplement 6Labeling	Approved	None posted
Mar 30, 1982	Supplement 1Manufacturing	Approved	None posted
Sep 27, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80021
Drugs@FDA: Overview at FDA
Company: Alcon

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