Ocusulf-10, Ocusulf-30

ANDA 80660, held by Miza Pharms USA. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 80660 (Ocusulf-10, Ocusulf-30), held by Miza Pharms USA, was first approved by FDA on Aug 24, 1972, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 24, 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
Aug 24, 1972	Original application	Approved	None posted

Products

2 strengths and forms


Ocusulf-1010% · solution/drops;ophthalmic	Sulfacetamide Sodium	Discontinued
Ocusulf-3030% · solution/drops;ophthalmic	Sulfacetamide Sodium	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Mar 7, 1996	Supplement 46Manufacturing	Approved	None posted
Mar 7, 1996	Supplement 45Labeling	Approved	None posted
Feb 13, 1996	Supplement 47Manufacturing	Approved	None posted
May 6, 1993	Supplement 44Labeling	Approved	None posted
Jul 7, 1992	Supplement 43Labeling	Approved	None posted
Jul 7, 1992	Supplement 42Manufacturing	Approved	None posted
Apr 4, 1990	Supplement 41Labeling	Approved	None posted
Aug 20, 1985	Supplement 37Manufacturing	Approved	None posted
Jun 19, 1985	Supplement 39Manufacturing	Approved	None posted
Jun 19, 1985	Supplement 34Manufacturing	Approved	None posted
Jun 19, 1985	Supplement 30Manufacturing	Approved	None posted
Dec 13, 1984	Supplement 35Manufacturing	Approved	None posted
Feb 7, 1984	Supplement 32Manufacturing	Approved	None posted
Jul 15, 1982	Supplement 29Manufacturing	Approved	None posted
Aug 24, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80660
Drugs@FDA: Overview at FDA
Company: Miza Pharms USA

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