Application 018681

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACTATED RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE	SOLUTION;IRRIGATION	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-2203	Lactated Ringers	Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride	B. Braun Medical Inc.	NDA	Current
0264-2203	Lactated Ringers	Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride	B. Braun Medical Inc.	NDA	Current
0264-2203	Lactated Ringers	Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride	B. Braun Medical Inc.	NDA	Current
0264-7389	Lactated Ringers Irrigation	sodium chloride, sodium lactate, potassium chloride and calcium chloride	B. Braun Medical Inc.	NDA	Current
0264-7389	Lactated Ringers Irrigation	sodium chloride, sodium lactate, potassium chloride and calcium chloride	B. Braun Medical Inc.	NDA	Current
0264-7389	Lactated Ringers Irrigation	sodium chloride, sodium lactate, potassium chloride and calcium chloride	B. Braun Medical Inc.	NDA	Current

Document, Submission type, Date table
Document	Submission type	Date
11276	SUPPL	2014-09-03