Sulfacel-15

ANDA 80024, held by Optopics. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 80024 (Sulfacel-15), held by Optopics, was first approved by FDA on Sep 29, 1970, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 29, 1970
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 29, 1970	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfacel-1515% · solution/drops;ophthalmic	Sulfacetamide Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jan 3, 1984	Supplement 9Manufacturing	Approved	None posted
Sep 29, 1970	Original application	Approved	None posted

Identifiers

Application: ANDA 80024
Drugs@FDA: Overview at FDA
Company: Optopics

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