Application 020625

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FEXOFENADINE HYDROCHLORIDE	CAPSULE;ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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
N020625-001	ALLEGRA	FEXOFENADINE HYDROCHLORIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1996-07-25

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020625-001	ALLEGRA	60MG	CAPSULE / ORAL	1996-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020625-001	ALLEGRA	60MG	CAPSULE / ORAL	1996-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1996-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1996-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1996-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1996-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1996-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1996-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1996-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1996-07-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	1996-07-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Wal-Fex	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	95d420ea-6337-304f-54c3-0c75be1608e2	2022-01-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
allergy relief	FEXOFENADINE HYDROCHLORIDE	Publix Super Markets Inc	76014f1e-fa48-4d64-9ce6-1eaebd0419fc	2022-01-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	DISCOUNT DRUG MART	c5106c63-af53-c169-e053-2a95a90afef2	2021-11-30	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	c1be67ea-9973-49e2-e053-2995a90a423c	2021-10-24	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
12HR Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CARDINAL HEALTH	ea5d0e55-2191-4094-b082-24b317f95752	2021-09-24	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Family Dollar Stores, Inc.	f532e9d5-6457-8bef-e83e-16050f20b03c	2020-02-19	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Sam's West Inc.	1c1f43c4-7128-37c4-83fe-7eefac3fd477	2019-10-07	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	7-eleven	d5914c05-e8db-4c79-82d0-a279d1304118	2019-06-20	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Safeway Inc	3c30a1dc-a13d-2522-d4d0-00c1e9dbab07	2017-12-11	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Consortium, LLC	d1d8d0ec-2bdd-fb07-a051-d6353e3c240c	2014-01-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Chain Drug Marketing Associate	8a1de8a1-808a-bc08-6c74-957d6f388eab	2014-01-22	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
57677	ORIG	2019-02-15
41490	SUPPL	2008-08-08
41489	SUPPL	2008-08-08
41491	SUPPL	2008-08-04
20770	SUPPL	2008-08-04
25341	SUPPL	2003-06-08
25340	SUPPL	2003-06-08
34974	SUPPL	2003-05-29
12863	SUPPL	2003-05-29
12862	ORIG	2003-04-30
2901	SUPPL	2001-07-11
51863	SUPPL	1900-01-01
51862	SUPPL	1900-01-01
51861	SUPPL	1900-01-01
51860	SUPPL	1900-01-01
51859	SUPPL	1900-01-01