Application 017037

Type: NDA
Sponsor: HIKMA

Related Records

Company: HIKMA

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	Yes	Yes
003	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	Yes	Yes
013	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/0.5ML	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-0391	Heparin Sodium	Heparin Sodium	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-0391	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0391	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0391	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0391	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0400	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0400	Heparin Sodium	Heparin Sodium	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-0400	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0400	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0400	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0410	Heparin Sodium	Heparin Sodium	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-0410	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0410	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0410	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-0410	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-2450	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-2450	Heparin Sodium	Heparin Sodium	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-2450	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-2450	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-2450	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-2460	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-2460	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-2460	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-2460	Heparin Sodium	Heparin Sodium	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-2460	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6199	Heparin Sodium	Heparin sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6199	Heparin Sodium	Heparin sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6199	Heparin Sodium	Heparin sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6199	Heparin Sodium	Heparin sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6204	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6204	Heparin Sodium	Heparin Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
55154-5130	Heparin Sodium	Heparin Sodium	Cardinal Health	NDA	Current
55154-5130	Heparin Sodium	Heparin Sodium	Cardinal Health	NDA	Current
55154-5130	Heparin Sodium	Heparin Sodium	Cardinal Health	NDA	Current
55154-5130	Heparin Sodium	Heparin Sodium	Cardinal Health 107, LLC	NDA	Current
55154-5130	Heparin Sodium	Heparin Sodium	Cardinal Health	NDA	Current
72572-250	Heparin Sodium	Heparin Sodium	Civica, Inc.	NDA	Current
72572-250	Heparin Sodium	Heparin Sodium	Civica, Inc.	NDA	Current
72572-255	Heparin Sodium	Heparin Sodium	Civica, Inc.	NDA	Current
72572-255	Heparin Sodium	Heparin Sodium	Civica, Inc.	NDA	Current

Documents

Document	Submission type	Date
80006	SUPPL	2024-10-28
79992	SUPPL	2024-10-25
62455	SUPPL	2020-04-06
62453	SUPPL	2020-04-06
59471	SUPPL	2019-07-26
48358	SUPPL	2017-05-12
48334	SUPPL	2017-05-10
10954	SUPPL	2012-01-26
13077	SUPPL	2011-12-29
10953	SUPPL	2011-03-04
13076	SUPPL	2011-02-28
13075	SUPPL	2009-11-09
10952	SUPPL	2009-10-16
534	SUPPL	2009-02-19
533	SUPPL	2008-01-09
33220	SUPPL	2007-12-21
13074	SUPPL	2006-10-13
10951	SUPPL	2006-10-05
33219	SUPPL	2005-09-07
33218	SUPPL	2005-09-07
13073	SUPPL	2005-09-07
13072	SUPPL	2005-09-07
10950	SUPPL	2005-09-07
532	SUPPL	2005-09-07