Isopto Cetamide

ANDA 80020, held by Alcon. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 80020 (Isopto Cetamide), held by Alcon, was first approved by FDA on May 5, 1971, with 18 approved supplements and 0 published complete response letters.

First approved: May 5, 1971
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
May 5, 1971	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isopto Cetamide15% · solution/drops;ophthalmic	Sulfacetamide Sodium	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Dec 23, 2002	Supplement 31Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 29Manufacturing	Approved	None posted
Apr 7, 2000	Supplement 30Manufacturing	Approved	None posted
May 7, 1999	Supplement 27Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 28Manufacturing	Approved	None posted
Mar 4, 1999	Supplement 26Manufacturing	Approved	None posted
Mar 27, 1998	Supplement 25Manufacturing	Approved	None posted
Jul 31, 1996	Supplement 24Labeling	Approved	None posted
Oct 5, 1995	Supplement 21Manufacturing	Approved	None posted
Aug 4, 1995	Supplement 20Manufacturing	Approved	None posted
Apr 21, 1995	Supplement 19Labeling	Approved	None posted
Aug 3, 1994	Supplement 18Manufacturing	Approved	None posted
Aug 3, 1993	Supplement 17Labeling	Approved	None posted
Jun 4, 1993	Supplement 14Manufacturing	Approved	None posted
Jun 4, 1993	Supplement 16Manufacturing	Approved	None posted
Jul 11, 1991	Supplement 15Labeling	Approved	None posted
Sep 15, 1989	Supplement 13Labeling	Approved	None posted
Apr 26, 1989	Supplement 12Manufacturing	Approved	None posted
May 5, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 80020
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