Application 021038

Type: NDA
Sponsor: HOSPIRA

Related Records

Company: HOSPIRA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	Yes	Yes
002	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	Yes	Yes
003	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	Yes	Yes
004	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	Yes	Yes
005	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9938	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	Henry Schein, Inc.	NDA	Current
0404-9938	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	Henry Schein, Inc.	NDA	Current
0404-9938	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	Henry Schein, Inc.	NDA	Current
0409-0155	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1174	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1434	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1454	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1454	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1638	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-1660	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3301	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3301	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3301	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3301	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-3301	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
0409-4596	Precedex	DEXMEDETOMIDINE HYDROCHLORIDE	Hospira, Inc.	NDA	Current
52584-638	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	NDA	Current
52584-638	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	NDA	Current
52584-638	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	NDA	Current
52584-638	PRECEDEX	DEXMEDETOMIDINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	NDA	Current

Documents

Document	Submission type	Date
85834	SUPPL	2026-05-05
85822	SUPPL	2026-05-04
79959	SUPPL	2024-10-22
79958	SUPPL	2024-10-22
72933	SUPPL	2022-12-20
72925	SUPPL	2022-12-19
71804	SUPPL	2022-08-15
71803	SUPPL	2022-08-15
71796	SUPPL	2022-08-15
71795	SUPPL	2022-08-15
62048	SUPPL	2020-03-05
62041	SUPPL	2020-03-05
35958	SUPPL	2016-04-12
4133	SUPPL	2016-04-12
21368	SUPPL	2015-07-21
26562	SUPPL	2014-12-01
4132	SUPPL	2014-12-01
4130	SUPPL	2014-12-01
35957	SUPPL	2014-11-20
35954	SUPPL	2014-11-20
14226	SUPPL	2014-11-20
21367	SUPPL	2013-10-21
26561	SUPPL	2013-06-18
4131	SUPPL	2013-06-18
35956	SUPPL	2013-06-17
14225	SUPPL	2013-06-17
35955	SUPPL	2013-03-19
64787	ORIG	2011-08-31
51513	SUPPL	2011-08-30
51512	SUPPL	2011-08-30
51511	SUPPL	2010-12-14
51510	SUPPL	2010-12-14
14224	SUPPL	2010-10-19
4129	SUPPL	2010-10-19
26560	SUPPL	2008-10-21
51509	SUPPL	2007-03-14
51508	SUPPL	2007-03-14
21366	ORIG	1999-12-17
14223	ORIG	1999-12-17
4128	ORIG	1999-12-17
63900	ORIG	1900-01-01
63899	ORIG	1900-01-01
58105	ORIG	1900-01-01
52610	SUPPL	1900-01-01
52609	SUPPL	1900-01-01
52608	SUPPL	1900-01-01