Application 017029

Type: NDA
Sponsor: FRESENIUS KABI USA

Related Records

Company: FRESENIUS KABI USA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	Yes	Yes
002	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	No	No
003	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	Yes	Yes
004	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	20,000 UNITS/ML	Yes	Yes
010	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	Yes	Yes
013	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	Yes	Yes
014	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	Yes	Yes
015	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	Yes	Yes
016	HEPARIN SODIUM IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	20,000 UNITS/ML	Yes	Yes
019	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	Yes	Yes
020	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	Yes	Yes
021	HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	INJECTABLE;INJECTION	40 UNITS/ML	Yes	No
022	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	INJECTABLE;INJECTION	50 UNITS/ML	Yes	Yes
023	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%	HEPARIN SODIUM	INJECTABLE;INJECTION	100 UNITS/ML	Yes	Yes
024	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	INJECTABLE;INJECTION	50 UNITS/ML	Yes	Yes
025	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%	HEPARIN SODIUM	INJECTABLE;INJECTION	100 UNITS/ML	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9979	Heparin Sodium	heparin sodium	Henry Schein, Inc.	NDA	Current
0404-9979	Heparin Sodium	heparin sodium	Henry Schein, Inc.	NDA	Current
51662-1409	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1409	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1409	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1409	HEPARIN SODIUM	HEPARIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1578	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM IN SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-111	Heparin Sodium	heparin sodium	General Injectables and Vaccines, Inc.	NDA	Current
52584-111	Heparin Sodium	heparin sodium	General Injectables and Vaccines, Inc.	NDA	Current
52584-111	Heparin Sodium	heparin sodium	General Injectables and Vaccines, Inc.	NDA	Current
52584-111	Heparin Sodium	heparin sodium	General Injectables and Vaccines, Inc.	NDA	Current
52584-262	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	NDA	Current
52584-540	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	NDA	Current
52584-542	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	NDA	Current
52584-542	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	NDA	Current
52584-542	Heparin Sodium	Heparin Sodium	General Injectables & Vaccines, Inc	NDA	Current
55154-9354	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9354	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9360	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9360	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9397	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9397	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9583	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
55154-9583	Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	NDA	Current
55154-9585	Heparin Sodium	HEPARIN SODIUM	Cardinal Health 107, LLC	NDA	Current
55154-9585	Heparin Sodium	HEPARIN SODIUM	Cardinal Health	NDA	Current
63323-118	Heparin Sodium	Heparin Sodium	Fresenius Kabi USA, LLC	NDA	Current
63323-118	Heparin Sodium	Heparin Sodium	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-262	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-276	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-276	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-276	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-459	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-517	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-517	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-517	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-517	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-518	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-518	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-518	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-518	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-522	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-522	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-522	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-522	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-523	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-523	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-523	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-523	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-540	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-542	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current
63323-542	Heparin Sodium	HEPARIN SODIUM	Fresenius Kabi USA, LLC	NDA	Current

Documents

Document	Submission type	Date
80005	SUPPL	2024-10-28
79991	SUPPL	2024-10-25
68640	SUPPL	2021-09-20
67735	SUPPL	2021-06-08
63804	SUPPL	2020-07-06
63795	SUPPL	2020-07-06
56692	SUPPL	2018-12-07
56509	SUPPL	2018-11-20
49553	SUPPL	2017-08-28
49550	SUPPL	2017-08-28
13071	SUPPL	2014-04-07
13070	SUPPL	2011-12-29
33217	SUPPL	2011-12-23
13069	SUPPL	2011-07-05
10949	SUPPL	2010-06-24
530	SUPPL	2010-06-14
33216	SUPPL	2008-10-03
529	SUPPL	2008-09-26
528	SUPPL	2002-03-22