Bleph-10

ANDA 84015, held by Allergan. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 84015 (Bleph-10), held by Allergan, was first approved by FDA on Jan 7, 1975, with 18 approved supplements and 0 published complete response letters.

First approved: Jan 7, 1975
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jan 7, 1975	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bleph-1010% · ointment;ophthalmic	Sulfacetamide Sodium	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Aug 15, 2001	Supplement 19Manufacturing	Approved	None posted
Jun 8, 2001	Supplement 20Manufacturing	Approved	None posted
Nov 15, 1999	Supplement 18Manufacturing	Approved	None posted
Jun 24, 1998	Supplement 17Manufacturing	Approved	None posted
Mar 27, 1998	Supplement 16Manufacturing	Approved	None posted
Mar 27, 1998	Supplement 15Manufacturing	Approved	None posted
Mar 27, 1998	Supplement 14Manufacturing	Approved	None posted
Mar 27, 1998	Supplement 13Manufacturing	Approved	None posted
Dec 12, 1996	Supplement 12Labeling	Approved	None posted
Dec 4, 1996	Supplement 11Manufacturing	Approved	None posted
Feb 22, 1996	Supplement 10Manufacturing	Approved	None posted
Feb 8, 1994	Supplement 9Labeling	Approved	None posted
Jun 29, 1993	Supplement 8Manufacturing	Approved	None posted
Jul 14, 1992	Supplement 6Manufacturing	Approved	None posted
Apr 16, 1991	Supplement 5Manufacturing	Approved	None posted
Apr 16, 1991	Supplement 4Manufacturing	Approved	None posted
Jul 22, 1988	Supplement 3Labeling	Approved	None posted
Feb 12, 1988	Supplement 2Manufacturing	Approved	None posted
Jan 7, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 84015
Drugs@FDA: Overview at FDA
Company: Allergan

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