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FEXOFENADINE HYDROCHLORIDE	CAPSULE;ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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N020625-001	ALLEGRA	FEXOFENADINE HYDROCHLORIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1996-07-25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N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`c2088c7a36db…`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N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`84e616aacf4f…`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N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`caaa826d4ba7…`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UTC	2026-02	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`011fe1cb6892…`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of this ZIP	2025-12	N020625-001	ALLEGRA	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	1996-07-25	`31067a03dcf5…`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 2 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	YYBA Corp	53e87aa4-9db3-9ded-e063-6294a90a319e	2026-06-10	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy 24 hour	FEXOFENADINE HYDROCHLORIDE	Select Consumer Group	2de81a41-8488-7e39-e063-6294a90a394b	2026-06-01	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Grocery Outlet, Inc.	441ce66e-515a-d380-e063-6394a90aec7d	2026-05-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	895de6e9-c5b6-42fe-b450-f5d8331ce2e3	2026-05-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	OHM LABORATORIES INC.	1a1afa95-570d-456e-b436-a0fcfaf68517	2026-05-05	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy, Travel BASIX	FEXOFENADINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	b82d993a-16ff-4037-a182-7010de8e1cdd	2026-04-27	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	e8a00fa1-79af-4ce6-885f-0ce12c5da836	2026-04-22	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Goodmeds Non Drowsy Allergy Relief	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	ae1322f5-85d6-4243-b384-2ce7f8c8d692	2026-04-20	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
careone allergy relief	FEXOFENADINE HYDROCHLORIDE	Retail Business Services, LLC	ce398856-e9a6-401d-8636-bc5771a7e28b	2026-04-14	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173	2026-04-14	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
allergy relief	FEXOFENADINE HYDROCHLORIDE	HyVee Inc	54635220-dd44-4baa-b929-9e52deb4c368	2026-03-25	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
ALLERGY RELIEF	FEXOFENADINE HYDROCHLORIDE	YYBA CORP	2dd5e6b0-2445-4419-b0e6-c62aadee6ea4	2026-03-18	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
berkley jensen allergy relief	FEXOFENADINE HYDROCHLORIDE	BJWC	2c6d9f8c-bc74-4e1a-bd51-50f84ab63a15	2026-02-06	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Nuvicare Hives Relief	FEXOFENADINE HYDROCHLORIDE	NUVICARE LLC	a8e11094-ca69-488d-a720-b8129f17f505	2026-01-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Gencare Hives Relief	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	ad0944f1-c5af-42cf-96c9-3140cbda66d8	2026-01-21	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	HYVEE INC	3e61ffb1-1c52-1ad5-e063-6294a90a6e3f	2026-01-13	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	e2bd23c7-dfba-463a-adbe-2183970da740	2026-01-13	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Hives 24hr	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	490b4c5f-448b-4563-928b-837117b59b9f	2026-01-12	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	AMZ789 LLC	1e46343f-d6b6-73ba-e063-6394a90acd94	2026-01-07	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Allergy Relief	FEXOFENADINE HYDROCHLORIDE	CVS Pharmacy	7cac266a-4de8-4af1-8324-b01823a3989a	2026-01-07	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
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