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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020742
Company: ALCON

Products on NDA 020742

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BSS	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	SOLUTION;IRRIGATION	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020742

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/1997	ORIG-1	Approval	Type 4 - New Combination	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2015	SUPPL-26	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020742Orig1s025,026ltr.pdf
11/06/2015	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020742Orig1s025,026ltr.pdf
11/15/2012	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
04/23/2009	SUPPL-20	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020742s020ltr.pdf
09/30/2004	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742s008ltr.pdf
05/25/2004	SUPPL-6	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742slr005,scp006ltr.pdf
05/25/2004	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742slr005,scp006ltr.pdf
04/15/2003	SUPPL-4	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020742s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20742scp004ltr.pdf
07/09/2003	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20742slr003_aqualase_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20742slr003ltr.pdf
10/30/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020742

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2015	SUPPL-26	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf
11/06/2015	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf
09/30/2004	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742s008lbl.pdf
05/25/2004	SUPPL-6	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf
05/25/2004	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf
07/09/2003	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20742slr003_aqualase_lbl.pdf
04/15/2003	SUPPL-4	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020742s004lbl.pdf

Therapeutic Equivalents for NDA 020742

BSS

SOLUTION;IRRIGATION; 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BALANCED SALT	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	SOLUTION;IRRIGATION	Prescription	No	AT	091387	B BRAUN
BSS	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	SOLUTION;IRRIGATION	Prescription	Yes	AT	020742	ALCON

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