Bss Plus

NDA 18469, held by Alcon. Calcium Chloride; Dextrose; Glutathione Disulfide; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate.

As of Nov 13, 2026, NDA 18469 (Bss Plus), held by Alcon, was first approved by FDA on Oct 28, 1981, with 44 approved supplements and 0 published complete response letters.

First approved: Oct 28, 1981
Review: Standard
Supplements approved: 44
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: BSS PLUS solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 45 submissions below

Date	Submission	Status	Documents
Oct 28, 1981	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bss Plus0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML · solution;irrigation	Calcium Chloride; Dextrose; Glutathione Disulfide; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate	RxReference drug

All 45 submissions, including labeling and manufacturing supplements


Apr 13, 2023	Supplement 60Labeling · Standard review	Approved	Letter
Apr 27, 2016	Supplement 56Labeling · Standard review	Approved	Label Letter
Nov 6, 2015	Supplement 55Manufacturing · Standard review	Approved	Letter Label
Nov 6, 2015	Supplement 54Labeling · Standard review	Approved	Letter Label
Feb 9, 2015	Supplement 53Manufacturing · Standard review	Approved	None posted
May 29, 2013	Supplement 52Manufacturing · Standard review	Approved	Label
Dec 20, 2004	Supplement 41Labeling · Standard review	Approved	Letter Label
Dec 20, 2004	Supplement 40Manufacturing · Standard review	Approved	Letter Label
May 25, 2004	Supplement 39Manufacturing · Standard review	Approved	Letter Label
May 25, 2004	Supplement 38Labeling · Standard review	Approved	Letter Label
Jul 16, 2003	Supplement 37Labeling · Standard review	Approved	Letter
Jul 16, 2003	Supplement 36Manufacturing · Standard review	Approved	Letter
Oct 18, 1999	Supplement 35Manufacturing · Standard review	Approved	None posted
Dec 29, 1998	Supplement 32Labeling · Standard review	Approved	None posted
Mar 20, 1998	Supplement 34Manufacturing · Standard review	Approved	None posted
Nov 3, 1997	Supplement 33Manufacturing · Standard review	Approved	None posted
May 2, 1997	Supplement 31Manufacturing · Standard review	Approved	None posted
Jan 14, 1997	Supplement 30Manufacturing · Standard review	Approved	None posted
Aug 19, 1994	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 13, 1994	Supplement 29Labeling · Standard review	Approved	None posted
Jun 15, 1993	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 8, 1993	Supplement 27Labeling · Standard review	Approved	None posted
Mar 24, 1993	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 23, 1992	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 30, 1991	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 29, 1990	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 29, 1990	Supplement 21Labeling	Approved	None posted
Oct 24, 1989	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 30, 1988	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 17, 1988	Supplement 14Labeling	Approved	None posted
Nov 8, 1988	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 30, 1988	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 8, 1988	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 10, 1987	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 27, 1987	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 29, 1986	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 13, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 24, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 22, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 17, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 14, 1983	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 8, 1982	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 8, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 25, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 28, 1981	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18469
Drugs@FDA: Overview at FDA
Company: Alcon

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