Application 020872

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
005	CHILDREN'S ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	Yes	No
006	CHILDREN'S ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	Yes	No
007	ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	Yes	No
008	ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	Yes	No
009	ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	Yes	No
010	ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-5619	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-5620	Fexofenadine Hydrochloride	Fexofenadine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4120	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4121	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4122	Allegra Allergy	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4122	Allegra Allergy	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4122	Allegra Allergy	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4122	Allegra Allergy	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4124	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4124	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4124	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4124	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4124	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4124	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4124	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4124	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4124	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4126	Allegra Hives 24hr	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4126	Allegra Hives 24hr	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4126	Allegra Hives 24hr	Fexofenadine Hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
41167-4131	Allegra Allergy	fexofenadine hydrochloride	Chattem, Inc.	NDA	Current
50090-1234	Allegra Allergy	fexofenadine hydrochloride	A-S Medication Solutions	NDA	Current
50090-1234	Allegra Allergy	fexofenadine hydrochloride	A-S Medication Solutions	NDA	Current
50090-1234	Allegra Allergy	fexofenadine hydrochloride	A-S Medication Solutions	NDA	Current
50090-1234	Allegra Allergy	fexofenadine hydrochloride	A-S Medication Solutions	NDA	Current
50090-1234	Allegra Allergy	fexofenadine hydrochloride	A-S Medication Solutions	NDA	Current
52904-190	Allegra Allergy	Fexofenadine hydrochloride	Select Corporation	NDA	Current
66715-9707	Allegra Allergy	Fexofenadine Hydrochloride	Lil' Drug Store Products, Inc	NDA	Current
66715-9707	Allegra Allergy	Fexofenadine Hydrochloride	Lil' Drug Store Products, Inc	NDA	Current
66715-9707	Allegra Allergy	Fexofenadine Hydrochloride	Lil' Drug Store Products, Inc	NDA	Current
66715-9707	Allegra Allergy	Fexofenadine Hydrochloride	Lil' Drug Store Products, Inc	NDA	Current
66715-9707	Allegra Allergy	Fexofenadine Hydrochloride	Lil' Drug Store Products, Inc	NDA	Current
67751-033	Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Navajo Manufacturing Co., Inc.	NDA	Current
67751-033	Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	NDA	Current
67751-033	Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	NDA	Current
67751-173	Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74973	SUPPL	2023-08-02
74971	SUPPL	2023-08-02
69082	SUPPL	2021-10-25
68986	SUPPL	2021-10-14
62318	SUPPL	2016-05-20
35555	SUPPL	2016-05-12
3631	SUPPL	2016-05-12
35554	SUPPL	2014-09-23
26103	SUPPL	2014-09-16
13657	SUPPL	2014-08-06
26102	SUPPL	2014-04-17
35552	SUPPL	2013-11-26
35553	SUPPL	2012-11-13
3630	SUPPL	2012-08-27
13656	SUPPL	2012-03-27
3629	SUPPL	2012-02-27
26101	SUPPL	2011-01-27
41777	SUPPL	2008-08-04
41778	SUPPL	2008-08-01
21037	SUPPL	2008-08-01
21036	SUPPL	2008-08-01
13655	SUPPL	2008-06-30
3628	SUPPL	2008-06-30
13654	SUPPL	2005-10-19
3627	SUPPL	2005-10-19
41776	SUPPL	2004-05-26
41775	ORIG	2004-05-26
21035	SUPPL	2004-05-26
21034	SUPPL	2004-05-26
3626	SUPPL	2003-06-08
3625	SUPPL	2003-06-08
35551	SUPPL	2003-05-29
35550	SUPPL	2003-05-29
26099	SUPPL	2001-10-29
26098	SUPPL	2001-10-29
26097	SUPPL	2001-10-29
26100	SUPPL	2001-07-11
35549	ORIG	2000-02-25
26096	ORIG	2000-02-25

Application 020872

Related Records#

Application Products#

NDC Listings For This Application#

Documents#