Bleph-10, Bleph-30

ANDA 80028, held by Allergan. Sulfacetamide Sodium.

As of Nov 15, 2026, ANDA 80028 (Bleph-10, Bleph-30), held by Allergan, was first approved by FDA on May 25, 1971, with 29 approved supplements and 0 published complete response letters.

First approved: May 25, 1971
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below

Date	Submission	Status	Documents
May 25, 1971	Original application	Approved	None posted

Products

2 strengths and forms


Bleph-1010% · solution/drops;ophthalmic	Sulfacetamide Sodium	DiscontinuedReference drug
Bleph-3030% · solution/drops;ophthalmic	Sulfacetamide Sodium	Discontinued

All 30 submissions, including labeling and manufacturing supplements


Nov 15, 2002	Supplement 49Manufacturing	Approved	None posted
Jul 3, 2002	Supplement 48Manufacturing	Approved	None posted
Aug 15, 2001	Supplement 47Manufacturing	Approved	None posted
Aug 7, 2001	Supplement 45Manufacturing	Approved	None posted
Feb 13, 2001	Supplement 44Manufacturing	Approved	None posted
Dec 8, 2000	Supplement 43Manufacturing	Approved	None posted
Sep 15, 1998	Supplement 42Manufacturing	Approved	None posted
Nov 14, 1997	Supplement 41Manufacturing	Approved	None posted
Nov 14, 1997	Supplement 40Manufacturing	Approved	None posted
Sep 27, 1994	Supplement 38Manufacturing	Approved	None posted
Jun 14, 1994	Supplement 39Labeling	Approved	None posted
Jun 29, 1993	Supplement 37Manufacturing	Approved	None posted
Jan 27, 1993	Supplement 36Labeling	Approved	None posted
Dec 12, 1991	Supplement 35Labeling	Approved	None posted
Dec 12, 1991	Supplement 32Manufacturing	Approved	None posted
Dec 12, 1991	Supplement 31Manufacturing	Approved	None posted
Dec 12, 1991	Supplement 30Manufacturing	Approved	None posted
Dec 12, 1991	Supplement 29Manufacturing	Approved	None posted
Dec 12, 1991	Supplement 28Manufacturing	Approved	None posted
Mar 27, 1991	Supplement 26Labeling	Approved	None posted
May 2, 1989	Supplement 33Manufacturing	Approved	None posted
Mar 29, 1988	Supplement 27Manufacturing	Approved	None posted
Oct 24, 1986	Supplement 23Manufacturing	Approved	None posted
Oct 24, 1986	Supplement 22Manufacturing	Approved	None posted
Dec 5, 1983	Supplement 20Manufacturing	Approved	None posted
Sep 28, 1982	Supplement 13Manufacturing	Approved	None posted
Sep 28, 1982	Supplement 12Manufacturing	Approved	None posted
Aug 16, 1982	Supplement 18Manufacturing	Approved	None posted
Jul 22, 1982	Supplement 15Manufacturing	Approved	None posted
May 25, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 80028
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