Application 018801

Type: NDA
Sponsor: HOSPIRA

Related Records

Company: HOSPIRA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (1ML)	Yes	No
002	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (10ML)	Yes	Yes
003	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (20ML)	Yes	Yes
004	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (50ML)	Yes	Yes
005	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (100ML)	Yes	Yes
006	STERILE WATER FOR INJECTION	STERILE WATER FOR INJECTION	LIQUID;N/A	100% (5.2ML)	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9959	Sterile Water	Water	Henry Schein, Inc.	NDA	Current
0404-9971	STERILE WATER	WATER	Henry Schein, Inc.	NDA	Current
0404-9971	STERILE WATER	WATER	Henry Schein, Inc.	NDA	Current
0409-4887	Sterile Water	WATER	Hospira, Inc.	NDA	Current
0409-4887	Sterile Water	WATER	Hospira, Inc.	NDA	Current
0409-4887	Sterile Water	WATER	Hospira, Inc.	NDA	Current
50090-2874	Sterile Water	WATER	A-S Medication Solutions	NDA	Current
50090-2874	Sterile Water	WATER	A-S Medication Solutions	NDA	Current
50090-2874	Sterile Water	WATER	A-S Medication Solutions	NDA	Current
50090-2874	Sterile Water	WATER	A-S Medication Solutions	NDA	Current
51662-1265	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1265	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1265	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1266	STERILE WATER	STERILE WATER	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1266	STERILE WATER	STERILE WATER	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1266	STERILE WATER	STERILE WATER	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1329	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1329	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1329	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1474	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1474	STERILE WATER	STERILE WATER	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-079	STERILE WATER	WATER	General Injectables and Vaccines, Inc.	NDA	Current
52584-079	STERILE WATER	WATER	General Injectables and Vaccines, Inc.	NDA	Current
52584-079	STERILE WATER	WATER	General Injectables and Vaccines, Inc.	NDA	Current
52584-079	STERILE WATER	WATER	General Injectables and Vaccines, Inc.	NDA	Current
52584-079	STERILE WATER	WATER	General Injectables and Vaccines, Inc.	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
52584-887	Sterile Water	Water	General Injectables & Vaccines, Inc	NDA	Current
55154-0127	Sterile Water	WATER	Cardinal Health	NDA	Current
55154-0127	Sterile Water	WATER	Cardinal Health	NDA	Current
55154-2379	Sterile Water	WATER	Cardinal Health	NDA	Current
55154-2379	Sterile Water	WATER	Cardinal Health	NDA	Current
64725-4887	Sterile Water	WATER	TYA Pharmaceuticals	NDA	Current
71872-7041	Sterile Water	WATER	Medical Purchasing Solutions, LLC	NDA	Current
71872-7182	Sterile Water	WATER	Medical Purchasing Solutions, LLC	NDA	Current
76420-082	Sterile Water	WATER	Asclemed USA, Inc.	NDA	Current
76420-082	Sterile Water	WATER	Asclemed USA, Inc.	NDA	Current

Documents

Document	Submission type	Date
16057	SUPPL	2009-07-08
16056	SUPPL	2004-04-20