Sulfacetamide Sodium

ANDA 78668, held by Sun Pharma Canada. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 78668 (Sulfacetamide Sodium), held by Sun Pharma Canada, was first approved by FDA on May 20, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: May 20, 2009
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
May 20, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfacetamide Sodium10% · lotion;topical	Sulfacetamide Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 30, 2012	Supplement 3Labeling · Standard review	Approved	None posted
May 20, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78668
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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