Application 020837

Type: NDA
Sponsor: OAK PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.021% BASE	Yes	Yes
002	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.042% BASE	Yes	Yes
003	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.0103% BASE	Yes	Yes
004	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.25% BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-171	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-171	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-171	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-171	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-171	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-172	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-172	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-172	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-172	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-172	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-173	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-173	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-173	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-173	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-173	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-174	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-174	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-174	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-174	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-174	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
21695-153	Xopenex	levalbuterol hydrochloride	Rebel Distributors Corp	NDA	Current
66993-021	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-021	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-021	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-021	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-021	Levalbuterol Hydrochloride	Levalbuterol hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-022	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-022	Levalbuterol Hydrochloride	levalbuterol hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-022	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-022	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-022	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-023	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-023	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-023	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-023	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-023	Levalbuterol hydrochloride	levalbuterol hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
70518-1227	Xopenex	Levalbuterol Hydrochloride	REMEDYREPACK INC.	NDA	Current
76204-002	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Ritedose Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
76204-003	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Ritedose Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57234	SUPPL	2019-01-16
57120	SUPPL	2019-01-04
13572	SUPPL	2015-04-14
3522	SUPPL	2015-04-02
13571	SUPPL	2015-01-29
3521	SUPPL	2015-01-23
26010	SUPPL	2014-04-02
35478	SUPPL	2014-04-01
3520	SUPPL	2014-01-22
35477	SUPPL	2013-09-24
26009	SUPPL	2013-09-23
13570	SUPPL	2012-09-11
3519	SUPPL	2012-09-10
41743	SUPPL	2006-10-26
26008	SUPPL	2006-09-18
26007	SUPPL	2003-07-28
13569	SUPPL	2002-01-30
26006	ORIG	1999-03-25
20999	ORIG	1999-03-25
13568	ORIG	1999-03-25
51290	SUPPL	1900-01-01
51289	SUPPL	1900-01-01
51288	SUPPL	1900-01-01

Application 020837

Related Records#

Application Products#

NDC Listings For This Application#

Documents#