Application 201370

Type: NDA
Sponsor: PFIZER

Related Records

Company: PFIZER

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
004	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0043	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0043	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0043	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0043	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0043	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0058	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0058	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0058	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0058	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0058	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0059	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0059	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0059	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0059	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0059	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0062	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0062	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0062	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0062	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0137	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0137	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0137	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0137	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0137	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents

Document	Submission type	Date
83532	SUPPL	2025-09-26
83524	SUPPL	2025-09-26
80011	SUPPL	2024-10-28
79996	SUPPL	2024-10-25
60080	SUPPL	2019-09-20
60079	SUPPL	2019-09-20
60074	SUPPL	2019-09-20
60073	SUPPL	2019-09-20
45035	SUPPL	2016-08-09
45019	SUPPL	2016-08-09
44836	ORIG	2012-06-20
43365	ORIG	2012-06-20
40068	ORIG	2011-07-25
32109	ORIG	2011-07-25