Application 021963

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALLEGRA	FEXOFENADINE HYDROCHLORIDE	SUSPENSION;ORAL	30MG/5ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021963-001	ALLEGRA	FEXOFENADINE HYDROCHLORIDE	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD	2006-10-16

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021963-001	ALLEGRA	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2006-10-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021963-001	ALLEGRA	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2006-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021963-001	ALLEGRA	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2006-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021963-001	ALLEGRA	30MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	2006-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021963-001	ALLEGRA	30MG/5ML	SUSPENSION / ORAL	RLD	2006-10-16	`3a93d1ddd44b…`

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 3 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	d7fe71e4-aada-40f5-86a8-bf0d7eb9b851	2025-12-26	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	0a4f4178-bea5-4995-99dc-96980cccdc8a	2025-12-26	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
topcare allergy relief	FEXOFENADINE HYDROCHLORIDE	Topco Associates LLC	e7658b5f-2d78-4f25-b1a3-e49198ca8f32	2025-12-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	bb47b839-3f49-4818-a62c-b6d2b09b15dc	2025-12-19	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	YYBA CORP	a1e80757-346f-4d88-8da7-55583c3a902b	2025-11-26	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Cabinet Allergy Relief Fexofenadine	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	9ed710e1-47f4-4d04-a509-12c8c97c192c	2025-11-05	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
ValuMeds 24-Hour Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	036f8eaa-7eb9-46f4-b42e-3c8c7e49e450	2025-10-23	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Cabinet Allergy Relief Fexofenadine	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	5237c8bd-0b20-4639-a740-f3001c4c2c94	2025-10-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
CVS Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	CVS Pharmacy	3d6c7b10-ed05-bbde-e063-6294a90ae92f	2025-10-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
good sense aller ease	FEXOFENADINE HYDROCHLORIDE	L. Perrigo Company	e533a008-b437-401e-ab50-bda31e6662d3	2025-10-09	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
up and up non drowsy allergy relief	FEXOFENADINE HYDROCHLORIDE	Target Corporation	d251b0a6-bc31-45b6-aaa8-f50f8336d959	2025-08-19	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Non-Drowsy Allergy Relief	FEXOFENADINE HYDROCHLORIDE	TARGET CORPORATION	3cf4b7fe-b1f7-b767-430a-655408f91753	2025-08-01	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	b961985e-0c18-b36f-d82e-32ff2d46fada	2025-07-18	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
24HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	b72c4802-1bcb-48bc-b4b9-72167ea4643e	2025-06-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Fexofenadine Hydrochloride Allergy	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	374f9271-b65b-69a9-e063-6394a90af36a	2025-06-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	ec55732c-a3db-4445-a06d-0f98b21ed134	2025-06-09	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	d3b6f04c-60d6-4ac3-9fb2-19eeb80f00a5	2025-06-01	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
exchange select aller ease	FEXOFENADINE HYDROCHLORIDE	Army & Air Force Exchange Service	6a9597a1-f024-4497-bc52-3d5482758822	2025-04-03	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Leader 24HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	e509800a-e33d-4d22-a6b4-97b7c73b1486	2025-04-01	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	FSA STORE INC.	276e9767-93c0-5932-e063-6394a90ab2d9	2025-03-07	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58961	SUPPL	2019-06-04
58906	SUPPL	2019-05-31
37960	SUPPL	2008-06-30
6547	SUPPL	2008-06-30
42361	ORIG	2008-03-14
28929	ORIG	2006-10-23
37959	ORIG	2006-10-18