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FEXOFENADINE HYDROCHLORIDE	CAPSULE;ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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N020625-001	ALLEGRA	FEXOFENADINE HYDROCHLORIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1996-07-25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N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`c2088c7a36db…`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N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`84e616aacf4f…`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N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`caaa826d4ba7…`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UTC	2026-02	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`011fe1cb6892…`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of this ZIP	2025-12	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`31067a03dcf5…`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 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Basic Care Allergy	FEXOFENADINE HYDROCHLORIDE	Amazon.com Services LLC	27202f58-a488-42cc-b63f-be892c5b4de2	2024-05-10	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Basic Care Allergy	FEXOFENADINE HYDROCHLORIDE	Amazon.com Services LLC	c29d281f-89dd-4c69-8572-6599400c660f	2024-04-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
allergy relief	FEXOFENADINE HYDROCHLORIDE	Walgreen Company	a0738300-7262-4e43-89a6-0d0a60bd14bd	2024-02-14	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Safeway, Inc.	348b79cf-1184-46d4-a0e5-fdc24afec1a5	2024-02-09	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Magno-Humphries, Inc.	1f8a2f98-7eba-48df-9589-58587d67ae0e	2024-01-03	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6dc0893-b81b-4f96-e053-6294a90a856f	2023-11-02	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	c4f9224c-4c3d-74bd-e053-2995a90a1452	2023-10-30	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	fabb8c0d-b4da-ab73-e053-6394a90ab8b5	2023-05-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
allergy relief	FEXOFENADINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	ccff9b0f-8ae5-057f-e053-2a95a90ac2b1	2023-05-17	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
kirkland signature aller fex	FEXOFENADINE HYDROCHLORIDE	Costco Wholesale Company	651d14d1-c5de-4cb9-9484-b05986e641ac	2023-05-02	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	de438313-9790-b4ea-2d28-7a19836cf5e2	2023-04-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Crcle Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Innovus Pharmaceuticals, Inc.	f7784610-7ca5-4489-b391-f2b3f3f6549b	2023-04-08	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Safrel Pharmaceuticals, LLC.	d6120f56-ab28-2696-e053-2995a90adf47	2023-03-28	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Proficient Rx LP	4a9b4b7f-0441-44d3-86c7-2542ef4b119a	2022-12-01	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HARRIS TEETER	e5429440-fc89-4200-e053-2995a90afc7d	2022-11-23	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	MARC GLASSMAN, INC.	c4f93336-cfd8-e023-e053-2995a90a9df0	2022-10-06	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Rite Aid Corporation	af2ef0bf-6cd2-b9a6-ff8f-6f50aac152ce	2022-06-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HEB	7cb25829-3aee-4a82-869d-ab4259626584	2022-05-31	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HEB	d8b852a1-7315-4047-aed6-cd40c7a39e70	2022-05-31	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	e43b561e-d68a-47af-be93-d710f0f77505	2022-02-22	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