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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020872-005	CHILDREN'S ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24
N020872-006	CHILDREN'S ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	RLD	2011-01-24
N020872-007	ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	RLD	2011-01-24
N020872-008	ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	RLD	2011-01-24
N020872-009	ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	RLD, RS	2011-01-24
N020872-010	ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	RLD, RS	2011-01-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`2680178bc6a6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allegra Allergy, Travel BASIX	FEXOFENADINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	b82d993a-16ff-4037-a182-7010de8e1cdd	2026-04-27	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872 ndc (product): 66715-9707
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	e8a00fa1-79af-4ce6-885f-0ce12c5da836	2026-04-22	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872 ndc (product): 67751-033
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173	2026-04-14	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872 ndc (product): 41167-4124 ndc (product): 41167-4121 ndc (product): 41167-4131 ndc (product): 41167-4120
Allegra Hives 24hr	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	490b4c5f-448b-4563-928b-837117b59b9f	2026-01-12	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872 ndc (product): 41167-4126
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	f061d6b1-89f7-4d5f-ac59-9c73408517c1	2025-02-19	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872 ndc (product): 41167-4122
ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	A-S Medication Solutions	b5ce28f8-f6c3-4113-9317-e1c98e5030ef	2024-07-30	Warnings	Exact identifier application applno (NDA): 020872 application number: NDA020872 ndc (product): 50090-1234

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 69 matching rows.

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