Application 018609

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	200 UNITS/100ML	No	No
002	HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	200 UNITS/100ML	No	No
003	HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	500 UNITS/100ML	No	No
004	HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	HEPARIN SODIUM	INJECTABLE;INJECTION	2,000 UNITS/1000ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0424	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA AUTHORIZED GENERIC	Current
0338-0424	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0424	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0424	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA AUTHORIZED GENERIC	Current
0338-0424	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA AUTHORIZED GENERIC	Current
0338-0424	Heparin Sodium and Sodium Chloride	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0424	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0428	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0428	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0428	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0428	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0428	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0431	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0431	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0431	Heparin Sodium and Sodium Chloride	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0431	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0431	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0431	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0431	Heparin Sodium and Sodium Chloride	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0431	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0431	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0431	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0433	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0433	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0433	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0433	Heparin Sodium and Sodium Chloride	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0433	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0433	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0433	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0433	Heparin Sodium and Sodium Chloride	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0433	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current
0338-0433	HEPARIN SODIUM IN SODIUM CHLORIDE	HEPARIN SODIUM	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69841	SUPPL	2022-01-12
69806	SUPPL	2022-01-04
59343	SUPPL	2019-07-16
59340	SUPPL	2019-07-16
959	SUPPL	2012-02-29
11245	SUPPL	2010-08-28
960	SUPPL	2010-08-20
40810	SUPPL	2008-04-02
40809	SUPPL	2008-04-02
33516	SUPPL	2003-04-14
11244	SUPPL	2003-04-14

Application 018609

Related Records#

Application Products#

NDC Listings For This Application#

Documents#