Application 020845

Type: NDA
Sponsor: MALLINCKRODT HOSP

Related Records

Company: MALLINCKRODT HOSP

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	INOMAX	NITRIC OXIDE	GAS;INHALATION	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	INOMAX	NITRIC OXIDE	GAS;INHALATION	800PPM	Yes	Yes
004	INOMAX	NITRIC OXIDE	GAS;INHALATION	4880PPM	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64693-002	INOmax	nitric oxide	INO THERAPEUTICS LLC	NDA	Current
64693-002	INOmax	nitric oxide	INO Therapeutics	NDA	Current

Documents

Document	Submission type	Date
73788	SUPPL	2023-03-17
73787	SUPPL	2023-03-17
57608	SUPPL	2019-02-14
57592	SUPPL	2019-02-14
21018	SUPPL	2016-07-27
21017	SUPPL	2016-07-27
3570	SUPPL	2016-04-07
35505	SUPPL	2015-10-15
13610	SUPPL	2015-10-15
26047	SUPPL	2015-10-14
26046	SUPPL	2015-10-14
13609	SUPPL	2013-03-08
3569	SUPPL	2013-03-05
13608	SUPPL	2010-12-22
3568	SUPPL	2010-12-22
3567	SUPPL	2009-11-19
13607	SUPPL	2009-09-17
26045	SUPPL	2008-01-09
3566	SUPPL	2004-06-16
26044	ORIG	1999-12-23
21016	ORIG	1999-12-23
13606	ORIG	1999-12-23
64026	ORIG	1900-01-01
53352	ORIG	1900-01-01
53351	ORIG	1900-01-01
53350	ORIG	1900-01-01