Application 076191

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076191-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31
A076191-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31
A076191-003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076191-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076191-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076191-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-08-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076191-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076191-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076191-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076191-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076191-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076191-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076191-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076191-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076191-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076191-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076191-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076191-003	AB	1	`ea99ee380514…`

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 · 118 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine Hydrochloride	FEXOFENADINE HYDROCHLORIDE	AMZ789 LLC	1e46343f-d6b6-73ba-e063-6394a90acd94	2026-01-07	Warnings	Name fallback brand name: Fexofenadine Hydrochloride 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
ValuMeds Non-Drowsy Allergy Relief Fexofenadine HCl	FEXOFENADINE HYDROCHLORIDE	Cabinet Health P.B.C.	f9ccd673-c65f-45c6-9863-26136eb816db	2026-01-06	Warnings	Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine Hydrochloride	FEXOFENADINE HCL	Northwind Health Company, LLC	f2b6c157-1af1-8d43-e053-2995a90aaf1a	2026-01-01	Warnings	Name fallback brand name: Fexofenadine Hydrochloride
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	d7fe71e4-aada-40f5-86a8-bf0d7eb9b851	2025-12-26	Warnings	Name fallback brand name: FEXOFENADINE HYDROCHLORIDE generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	0a4f4178-bea5-4995-99dc-96980cccdc8a	2025-12-26	Warnings	Name fallback brand name: FEXOFENADINE HYDROCHLORIDE 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 brand name: FEXOFENADINE HYDROCHLORIDE 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 HCL	Major Pharmaceuticals	c34cda59-8a63-48ab-a19d-c06a1878f5da	2025-07-18	Warnings	Name fallback brand name: Fexofenadine Hydrochloride
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Walgreens Company	b961985e-0c18-b36f-d82e-32ff2d46fada	2025-07-18	Warnings	Name fallback brand name: Fexofenadine hydrochloride 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

Reported adverse events (FAERS/openFDA)#

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