Blephamide

NDA 12813, held by Allergan. Prednisolone Acetate; Sulfacetamide Sodium.

As of Nov 14, 2026, NDA 12813 (Blephamide), held by Allergan, was first approved by FDA on Sep 18, 1961, with 33 approved supplements and 0 published complete response letters.

First approved: Sep 18, 1961
Review: Standard
Supplements approved: 33
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below

Date	Submission	Status	Documents
Sep 18, 1961	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Blephamide0.2%;10% · suspension;ophthalmic	Prednisolone Acetate; Sulfacetamide Sodium	DiscontinuedReference drug

All 34 submissions, including labeling and manufacturing supplements


Jul 18, 2017	Supplement 62Labeling · Standard review	Approved	Letter Label
Mar 19, 2003	Supplement 57Labeling · Standard review	Approved	None posted
Apr 12, 2002	Supplement 54Manufacturing · Standard review	Approved	None posted
Dec 4, 2001	Supplement 53Manufacturing · Standard review	Approved	None posted
Apr 12, 2001	Supplement 52Manufacturing · Standard review	Approved	None posted
Mar 26, 2001	Supplement 51Manufacturing · Standard review	Approved	None posted
Oct 2, 2000	Supplement 50Manufacturing · Standard review	Approved	None posted
Apr 21, 2000	Supplement 49Manufacturing · Standard review	Approved	None posted
Apr 21, 2000	Supplement 48Manufacturing · Standard review	Approved	None posted
Dec 3, 1999	Supplement 47Manufacturing · Standard review	Approved	None posted
Aug 3, 1998	Supplement 43Labeling · Standard review	Approved	None posted
Aug 3, 1998	Supplement 29Manufacturing · Standard review	Approved	None posted
May 21, 1998	Supplement 45Manufacturing · Standard review	Approved	None posted
Jan 9, 1998	Supplement 46Manufacturing · Standard review	Approved	None posted
Sep 30, 1997	Supplement 44Manufacturing · Standard review	Approved	None posted
Dec 2, 1996	Supplement 42Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 40Manufacturing · Standard review	Approved	None posted
Jun 22, 1994	Supplement 41Manufacturing · Standard review	Approved	None posted
Apr 13, 1993	Supplement 39Manufacturing · Standard review	Approved	None posted
Aug 6, 1990	Supplement 38Manufacturing · Standard review	Approved	None posted
Nov 7, 1989	Supplement 37Manufacturing · Standard review	Approved	None posted
Mar 14, 1989	Supplement 36Manufacturing · Standard review	Approved	None posted
Nov 10, 1986	Supplement 35Manufacturing · Standard review	Approved	None posted
Jul 18, 1986	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 7, 1986	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 14, 1986	Supplement 34Manufacturing · Standard review	Approved	None posted
Aug 23, 1985	Supplement 31Manufacturing · Standard review	Approved	None posted
Jul 9, 1985	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 15, 1982	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 15, 1982	Supplement 23Manufacturing · Standard review	Approved	None posted
Sep 25, 1981	Supplement 25Manufacturing · Standard review	Approved	None posted
May 8, 1980	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 7, 1978	Supplement 20Manufacturing · Standard review	Approved	None posted
Sep 18, 1961	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 12813
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