Bss

NDA 20742, held by Alcon. Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Citrate.

As of Nov 13, 2026, NDA 20742 (Bss), held by Alcon, was first approved by FDA on Dec 10, 1997, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 10, 1997
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Dec 10, 1997	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bss0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML · solution;irrigation	Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Citrate	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Nov 6, 2015	Supplement 26Manufacturing · Standard review	Approved	Letter Label
Nov 6, 2015	Supplement 25Labeling · Standard review	Approved	Letter Label
Nov 15, 2012	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 23, 2009	Supplement 20Manufacturing · Standard review	Approved	Letter
Sep 30, 2004	Supplement 8Labeling · Standard review	Approved	Label Letter
May 25, 2004	Supplement 6Manufacturing · Standard review	Approved	Label Letter
May 25, 2004	Supplement 5Labeling · Standard review	Approved	Label Letter
Jul 9, 2003	Supplement 3Labeling · Standard review	Approved	Label Letter
Apr 15, 2003	Supplement 4Manufacturing · Standard review	Approved	Letter Label
Oct 30, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 10, 1997	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 20742
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

Bss