Sulfacetamide Sodium

ANDA 80029, held by Padagis US. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 80029 (Sulfacetamide Sodium), held by Padagis US, was first approved by FDA on Dec 22, 1971, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1971
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 22, 1971	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfacetamide Sodium10% · ointment;ophthalmic	Sulfacetamide Sodium	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Mar 7, 1996	Supplement 37Manufacturing	Approved	None posted
Oct 27, 1995	Supplement 35Manufacturing	Approved	None posted
Oct 27, 1995	Supplement 36Manufacturing	Approved	None posted
Aug 3, 1995	Supplement 33Manufacturing	Approved	None posted
Aug 3, 1995	Supplement 34Manufacturing	Approved	None posted
Mar 13, 1995	Supplement 31Manufacturing	Approved	None posted
Jan 19, 1995	Supplement 32Labeling	Approved	None posted
Sep 14, 1993	Supplement 30Labeling	Approved	None posted
May 2, 1991	Supplement 29Manufacturing	Approved	None posted
May 19, 1989	Supplement 27Labeling	Approved	None posted
Mar 25, 1988	Supplement 26Labeling	Approved	None posted
Aug 1, 1983	Supplement 25Manufacturing	Approved	None posted
Jul 8, 1982	Supplement 20Manufacturing	Approved	None posted
Dec 22, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 80029
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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