Application 017641

Type: NDA
Sponsor: ICU MEDICAL INC

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	INJECTABLE;INJECTION	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7953	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7953	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7953	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	Hospira, Inc.	NDA	Current
0990-7953	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7953	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7953	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7953	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7953	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7953	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7953	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	ICU Medical Inc.	NDA	Current
51662-1300	LACTATED RINGERS	SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1300	LACTATED RINGERS	SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1300	LACTATED RINGERS	SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1331	RINGERS	SODIUM LACTATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1331	RINGERS	SODIUM LACTATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1331	RINGERS	SODIUM LACTATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1516	LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
76420-129	Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE	Asclemed USA, Inc.	NDA	Current