Application 075503

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
17478-920	BALANCED SALT	Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate	Akorn	ANDA	Current
17478-920	BALANCED SALT	Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate	Akorn, Inc.	ANDA	Current
17478-920	BALANCED SALT	Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate	Akorn, Inc.	ANDA	Current
17478-921	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate and Trisodium Citrate Dihydrate	Akorn, Inc.	ANDA	Current
17478-921	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate and Trisodium Citrate Dihydrate	Akorn	ANDA	Current
17478-921	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate and Trisodium Citrate Dihydrate	Akorn, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
8697	ORIG	2006-10-02