Application 091387

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BALANCED SALT	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE	SOLUTION;IRRIGATION	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-1945	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate	B. Braun Medical Inc.	ANDA	Current
0264-1945	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate	B. Braun Medical Inc.	ANDA	Current
0264-2514	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate	B. Braun Medical Inc.	ANDA	Current
0264-2514	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate	B. Braun Medical Inc.	ANDA	Current
0264-2514	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate	B. Braun Medical Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
9335	ORIG	2010-02-17