Application 019445

Type: NDA
Sponsor: HOSPIRA

Related Records

Company: HOSPIRA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 50% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	500MG/ML	Yes	No
002	DEXTROSE 25%	DEXTROSE	INJECTABLE;INJECTION	250MG/ML	Yes	Yes
003	DEXTROSE 50%	DEXTROSE	INJECTABLE;INJECTION	500MG/ML	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9844	Infant Dextrose	Dextrose	Henry Schein, Inc.	NDA	Current
0404-9844	Infant Dextrose	Dextrose	Henry Schein, Inc.	NDA	Current
0404-9844	Infant Dextrose	Dextrose	Henry Schein, Inc.	NDA	Current
0404-9845	Dextrose	Dextrose Monohydrate	Henry Schein, Inc.	NDA	Current
0404-9845	Dextrose	Dextrose Monohydrate	Henry Schein, Inc.	NDA	Current
0404-9847	Dextrose	Dextrose Monohydrate	Henry Schein, Inc.	NDA	Current
0404-9847	Dextrose	Dextrose Monohydrate	Henry Schein, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-1775	Dextrose	Dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-6648	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
0409-7517	Dextrose	DEXTROSE MONOHYDRATE	Hospira, Inc.	NDA	Current
50090-2942	Dextrose	DEXTROSE MONOHYDRATE	A-S Medication Solutions	NDA	Current
51662-1213	25% Dextrose Infant	25% Dextrose Infant	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1213	25% Dextrose Infant	25% Dextrose Infant	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1213	25% Dextrose Infant	25% Dextrose Infant	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1213	25% Dextrose Infant	25% Dextrose Infant	HF Acquisition Co. LLC, DBA Health First	NDA	Current
51662-1215	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1215	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1215	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1215	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1216	50% DEXTROSE	50% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1216	50% DEXTROSE	50% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1216	50% DEXTROSE	50% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1216	50% DEXTROSE	50% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-517	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-648	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-648	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-648	Dextrose	Dextrose Monohydrate	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
52584-775	Infant Dextrose	Dextrose	General Injectables & Vaccines, Inc	NDA	Current
55154-6977	Dextrose	DEXTROSE MONOHYDRATE	Cardinal Health	NDA	Current
55154-6977	Dextrose	DEXTROSE MONOHYDRATE	Cardinal Health	NDA	Current
70518-1427	Dextrose	DEXTROSE MONOHYDRATE	REMEDYREPACK INC.	NDA	Current
71872-7003	Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7003	Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7003	Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7057	Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7057	Dextrose	DEXTROSE MONOHYDRATE	Medical Purchasing Solutions, LLC	NDA	Current
71872-7214	Dextrose	Dextrose monohydrate	Medical Purchasing Solutions, LLC	NDA	Current

Documents

Document	Submission type	Date
82964	SUPPL	2025-07-28
82963	SUPPL	2025-07-28
82953	SUPPL	2025-07-28
82952	SUPPL	2025-07-28
20242	SUPPL	1998-11-23
20241	SUPPL	1998-11-23
17406	SUPPL	1998-11-23
1325	SUPPL	1998-11-23