Details for New Drug Application (NDA): 018469

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NDA 018469 describes BSS PLUS, which is a drug marketed by Alcon and is included in one NDA. It is available from one supplier. Additional details are available on the BSS PLUS profile page.

The generic ingredient in BSS PLUS is calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

Summary for 018469

Tradename:	BSS PLUS
Applicant:	Alcon
Ingredient:	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate
Patents:	0

Suppliers and Packaging for NDA: 018469

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BSS PLUS	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018469	NDA	Alcon Laboratories, Inc.	0065-0800	0065-0800-94	1 KIT in 1 PACKAGE (0065-0800-94) * 480 mL in 1 BAG * 20 mL in 1 VIAL, GLASS
BSS PLUS	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018469	NDA	Alcon Laboratories, Inc.	0065-0800	0065-0800-50	1 KIT in 1 PACKAGE (0065-0800-50) * 480 mL in 1 BOTTLE, GLASS * 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;IRRIGATION			Strength	0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 018469

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon	BSS PLUS	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018469-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Alcon	BSS PLUS	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018469-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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