Application 016366

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	900MG/100ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7983	Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7983	Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7983	Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7983	Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7984	Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7984	Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7984	Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	NDA	Current
0409-7984	Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	NDA	Current
0990-7983	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7983	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7983	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7983	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7983	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7983	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7983	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7983	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7983	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7984	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7984	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7984	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7984	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7984	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7984	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7984	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7984	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7984	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
0990-7984	Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	NDA	Current
51662-1258	SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1258	SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1258	SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1260	0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1260	0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1260	0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1308	0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1308	0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1308	0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1318	SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1318	SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1318	SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1517	0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1518	0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1520	0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1522	SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49834	SUPPL	2017-09-22
49831	SUPPL	2017-09-22

Application 016366

Related Records#

Application Products#

NDC Listings For This Application#

Documents#