Sulten-10

ANDA 87818, held by Bausch And Lomb. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 87818 (Sulten-10), held by Bausch And Lomb, was first approved by FDA on Feb 3, 1983, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 3, 1983
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
Feb 3, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulten-1010% · solution/drops;ophthalmic	Sulfacetamide Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 12, 1988	Supplement 17Labeling	Approved	None posted
Feb 3, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87818
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

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